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USFDA Warning Letters to Indian Pharma Companies

Warning letters from the US FDA to listed Indian pharma companies and their units, newest first, with a link to each letter on fda.gov. A close-out letter means FDA considers the issues resolved.

Show tracked companies only
IssuedCompanySubjectIssuing officeClose-outLetter
09 Apr 2026 Medical Products Laboratories, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
07 Apr 2026 Smart Vending Services, LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
03 Apr 2026 mohawksmoke.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
02 Apr 2026 Purolea Cosmetics Lab CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
02 Apr 2026 Beauty of Aztlan LLC Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
01 Apr 2026 Online Rx Medz Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
01 Apr 2026 Dry Springs Pharmacy Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
01 Apr 2026 Pure Indulgence Aesthetics Drug Supply Chain Security Act (DSCSA) ViolationsCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
01 Apr 2026 Rxgoodusa Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
31 Mar 2026 FormPour Unapproved New Drugs Sold Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
31 Mar 2026 Gram Peptides Unapproved New Drugs Sold Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
31 Mar 2026 Lovega LLC dba Pink Pony Peptides Unapproved New Drugs Sold Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
31 Mar 2026 Guangzhou Huli Technology Co., Ltd. dba Fantasy Face Unapproved New Drugs Sold Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
31 Mar 2026 Mile High Compounds LLC Unapproved New Drugs Sold Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
31 Mar 2026 Prime Sciences Unapproved New Drugs Sold Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
31 Mar 2026 PekCura Labs Unapproved New Drugs Sold Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
31 Mar 2026 Global Tobacco, LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
27 Mar 2026 buydeltas.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
27 Mar 2026 Ehsan Sadri, M.D. Clinical InvestigatorCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
26 Mar 2026 Henan Lvyuan Pharmaceutical Co. Ltd. CGMP/API/AdulteratedCenter for Veterinary Medicine — fda.gov ↗
25 Mar 2026 Medline Industries, LP CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
20 Mar 2026 matesbrand.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
18 Mar 2026 Yangzhou H&R Plastic Daily Chemical Co., Ltd. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
18 Mar 2026 Schlechter Farms Inc. CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedHuman Foods Program — fda.gov ↗
16 Mar 2026 Microbiological Testing & Consulting, LLC CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
13 Mar 2026 ImmunityBio, Inc. False & Misleading Claims/MisbrandedThe Office of Prescription Drug Promotion (OPDP) — fda.gov ↗
12 Mar 2026 Patcos Cosmetics Pvt. Ltd. Finished Drug Products/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
11 Mar 2026 Flowchem Pharma Private Limited CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
11 Mar 2026 OraLabs, Inc. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
09 Mar 2026 Vedic Lifesciences Pvt. Ltd. Good Laboratory Practice (GLP) for Nonclinical Laboratory StudiesCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
06 Mar 2026 Half Hill Farm Inc. Unapproved New Drugs/MisbrandedHuman Foods Program — fda.gov ↗
06 Mar 2026 prilla.com/us Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
05 Mar 2026 SSS AUSTAR LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
05 Mar 2026 Novo Nordisk Inc. Postmarketing Adverse Drug Experience Reporting RequirementsCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
05 Mar 2026 Life Plus Style Gourmet LLC Foreign Supplier Verification Program (FSVP)Office of Inspections and Investigations — fda.gov ↗
04 Mar 2026 Citra100mg Unapproved New Drugs/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
03 Mar 2026 Tentamus India Private Limited CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
03 Mar 2026 Simtra BioPharma Solutions CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
03 Mar 2026 Fareva Morton Grove CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
03 Mar 2026 Barcelona Nut Company Inc. CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedHuman Foods Program — fda.gov ↗
03 Mar 2026 Ocean Group Inc. Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsHuman Foods Program — fda.gov ↗
27 Feb 2026 thesnuslife.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
27 Feb 2026 Rio Verde Food Service Inc. Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsHuman Foods Program — fda.gov ↗
27 Feb 2026 idripejuice.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
27 Feb 2026 snushaven.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
26 Feb 2026 Longhorn Vaccines and Diagnostics LLC CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
24 Feb 2026 Trangs Group USA Incorporated Foreign Supplier Verification Program (FSVP)Office of Inspections and Investigations — fda.gov ↗
24 Feb 2026 IsoTis OrthoBiologics, Inc. CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
20 Feb 2026 Aspen Aesthetics dba Fifty 410 False & Misleading Claims/Misbranded (Telehealth)Center for Drug Evaluation and Research (CDER) — fda.gov ↗
20 Feb 2026 Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics False & Misleading Claims/Misbranded (Telehealth)Center for Drug Evaluation and Research (CDER) — fda.gov ↗
20 Feb 2026 Genesis Health International Inc. dba Genesis False & Misleading Claims/Misbranded (Telehealth)Center for Drug Evaluation and Research (CDER) — fda.gov ↗
20 Feb 2026 FitRX, LLC dba FitRx False & Misleading Claims/Misbranded (Telehealth)Center for Drug Evaluation and Research (CDER) — fda.gov ↗
20 Feb 2026 BluefitMD False & Misleading Claims/Misbranded (Telehealth)Center for Drug Evaluation and Research (CDER) — fda.gov ↗
20 Feb 2026 Premium Health Management Inc. dba Premium Health False & Misleading Claims/Misbranded (Telehealth)Center for Drug Evaluation and Research (CDER) — fda.gov ↗
20 Feb 2026 Bliv Wellness LLC dba Bliv False & Misleading Claims/Misbranded (Telehealth)Center for Drug Evaluation and Research (CDER) — fda.gov ↗
19 Feb 2026 El Rey USA Meats & Seafood Inc. Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsOffice of Inspections and Investigations — fda.gov ↗
17 Feb 2026 Raw Bistro Inc. CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedCenter for Veterinary Medicine — fda.gov ↗
10 Feb 2026 A TO Z Distributor Inc Foreign Supplier Verification Program (FSVP)Office of Inspections and Investigations — fda.gov ↗
16 Jan 2026 Feng Foods Trading Inc. Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsOffice of Inspections and Investigations — fda.gov ↗
19 Dec 2025 Exactech, Inc. dba Advita Ortho CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
01 Dec 2025 Apothecary Pharma, LLC Compounding Pharmacy/Adulterated Drug ProductsCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
12 Nov 2025 Physitemp Instruments, LLC CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
03 Sep 2025 Avertix Medical, Inc. CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
15 Aug 2025 Meds For Vets, LLC Unapproved New Animal Drug/Adulterated/MisbrandedCenter for Veterinary Medicine — fda.gov ↗
27 May 2025 Grow Gold Land, Inc. Foreign Supplier Verification Program (FSVP)Office of Inspections and Investigations — fda.gov ↗
22 May 2025 Artisan Vapor Company Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
22 May 2025 Kure CBD & Vape Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
16 May 2025 vapordna.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
16 May 2025 denverelectroniccigarettes.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
16 May 2025 vaporhatch.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
15 May 2025 ECIGRUSA LLC, d/b/a Worldwide Vape Distribution Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
15 May 2025 Kure CBD & Vape Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
15 May 2025 Wise Guys Vapes Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
15 May 2025 Black Note, Inc. Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
15 May 2025 Madvapes Vape Shop Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
13 May 2025 AACE Pharmaceuticals, Inc. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
09 May 2025 ejuice-online.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
09 May 2025 Kabe Labortechnik GmbH CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
09 May 2025 NeuroSync, Inc. CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
09 May 2025 lostmary.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
08 May 2025 FishMoxFishFlex/Simple Pet Health LLC Unapproved New Animal Drug/MisbrandedCenter for Veterinary Medicine — fda.gov ↗
08 May 2025 Product Society LLC CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
07 May 2025 Excelvision Fareva CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
06 May 2025 Shenzhen Hengkaifeng Commerce and Trade Co., Ltd Failure to List/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
06 May 2025 Wailea Agricultural Group, Inc. CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedHuman Foods Program — fda.gov ↗
05 May 2025 Sedecal S.A. CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
05 May 2025 Supreme Rejuvenation, LLC Unapproved New Drugs/MisbrandedCenter for Biologics Evaluation and Research — fda.gov ↗
02 May 2025 San Juan Produce LLC Foreign Supplier Verification Program (FSVP)Office of Inspections and Investigations — fda.gov ↗
21 Apr 2025 Amore Produce, LLC Foreign Supplier Verification Program (FSVP)Center for Tobacco Products — fda.gov ↗
15 Apr 2025 Gluten Free Remedies LLC Dietary Supplement/MisbrandedHuman Foods Program — fda.gov ↗
04 Apr 2025 Wuxi Medical Instrument Factory Co., Ltd. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
02 Apr 2025 Taizhou Jingshang Cosmetics Technology Co., Ltd. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
01 Apr 2025 NWL Netherlands Services B.V. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
31 Mar 2025 DRG Instruments GmbH Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceCenter for Devices and Radiological Health — fda.gov ↗
27 Mar 2025 Yiling Pharmaceutical Ltd. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
25 Mar 2025 Latro Inc. Adulterated Human Foods/MisbrandedHuman Foods Program — fda.gov ↗
25 Mar 2025 BioAsia Worldwide Sdn Bhd CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
24 Mar 2025 United Health Products, Inc. Bioresearch Monitoring Program/Institutional Review Board (IRB)Center for Devices and Radiological Health — fda.gov ↗
04 Mar 2025 ProRx, LLC Compounding Pharmacy/Adulterated Drug ProductsCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
27 Feb 2025 The Vapor Club LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
27 Feb 2025 Elk River Vapor Shop Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
26 Feb 2025 Granules India Limited CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
25 Feb 2025 TKTX Store Unapproved New Drugs/Misbranded/OTCCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
25 Feb 2025 TKTX Numbing Cream USA Unapproved New Drugs/Misbranded/OTCCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
25 Feb 2025 TKTX USA Unapproved New Drugs/Misbranded/OTCCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
25 Feb 2025 TKTX Numb Store Unapproved New Drug and Misbranded/OTCCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
21 Feb 2025 Loveli Design, LLC d/b/a Alice in Vapeland Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
14 Feb 2025 Walker Enterprises, LLC d/b/a MaddCatt Vapor Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
14 Feb 2025 A-Z Tobacco Inc d/b/a A-Z Tobacco and Vapor Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
14 Feb 2025 Steep Slope Vape Supply Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
14 Feb 2025 Smoke and Vape Inc d/b/a Backdoor Smoke Shop Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
14 Feb 2025 Gorilla Vapes of East Brunswick Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
14 Feb 2025 Route 66 Vapor Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
14 Feb 2025 Sperm Bank, Inc. dba Fertility Center of California Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Center for Biologics Evaluation and Research (CBER) ✓ Closed out fda.gov ↗
11 Feb 2025 Chem-Tech, Ltd. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
10 Feb 2025 Marshalls Traditional Healthcare CC CGMP/Finished Pharmaceutical/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
10 Feb 2025 ABR Laboratory LLC CGMP/Finished Pharmaceutical/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
06 Feb 2025 Tyche Industries Ltd CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
05 Feb 2025 Jagsonpal Pharmaceuticals Limited CGMP/Finished Pharmaceutical/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
05 Feb 2025 Chengdu Innovation Pharmaceutical Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
04 Feb 2025 Wuhu Nuowei Chemistry Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
04 Feb 2025 ISOThrive, Inc. Clinical InvestigatorCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
30 Jan 2025 Strukmyer LLC dba Strukmyer Medical CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
29 Jan 2025 AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
28 Jan 2025 Shantou Kangjie Daily Chemical Industry Co., Ltd CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
27 Jan 2025 Garcia Fresh Vegetables LLC Foreign Supplier Verification Program (FSVP)Division of Southwest Imports — fda.gov ↗
27 Jan 2025 Imperial Palace Commodity -Dongguan- Co., Ltd. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
23 Jan 2025 Center for Instrumental Analysis of China Pharmaceutical University CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
21 Jan 2025 Robbins Instruments, LLC Medical Device/Misbranded/Unapproved Device/Quality System Regulation"ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality" — fda.gov ↗
21 Jan 2025 Kardesler Ucan Yaglar Sanayi Anonim Sirketi CGMP/Finished Pharmaceutical/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
17 Jan 2025 BioStem Life Sciences Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Center for Biologics Evaluation and Research (CBER) — fda.gov ↗
17 Jan 2025 Chara Biologics, Inc. CGMP/Deviations/Biologics License Application (BLA)Center for Biologics Evaluation and Research (CBER) — fda.gov ↗
16 Jan 2025 Mihon Corp. d/b/a VitalityVita and Boulla, LLC Unapproved New Drugs/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
15 Jan 2025 Sanofi CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
14 Jan 2025 Radhaswamy Inc. dba Raja Foods LLC Foreign Supplier Verification Program (FSVP)Division of Northeast Imports — fda.gov ↗
13 Jan 2025 www.weightcrunchshop.com Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
08 Jan 2025 Midwest Goods Inc., d/b/a Midwest Distribution and Midwest Distribution Illinois Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
08 Jan 2025 Ecig Charleston LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
08 Jan 2025 Atlanta Supersource, Inc. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
08 Jan 2025 Reedhill Ventures LLC, d/b/a Vape On Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
07 Jan 2025 Elite Brothers, LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
30 Dec 2024 Evolutionary Biologics Inc. Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Center for Biologics Evaluation and Research — fda.gov ↗
26 Dec 2024 Baldwin Richardson Foods Pennsauken, LLC Low Acid Canned Food Regulation/AdulteratedHuman Foods Program — fda.gov ↗
26 Dec 2024 Reunipeche SAS Seafood HACCP/CGMP for Foods/AdulteratedHuman Foods Program — fda.gov ↗
23 Dec 2024 Rey de los Camarones S. A. Seafood HACCP/CGMP for Foods/AdulteratedHuman Foods Program — fda.gov ↗
23 Dec 2024 Nyumbani Hakuna Matata LLC Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsDivision of Northern Border Imports — fda.gov ↗
23 Dec 2024 By George Food Specialties Inc. Foreign Supplier Verification Program (FSVP)Division of Northern Border Imports — fda.gov ↗
20 Dec 2024 Golden Grains Bakery CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/AdulteratedHuman Foods Program — fda.gov ↗
19 Dec 2024 Viatris, Inc. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
19 Dec 2024 Fagron Compounding Services, LLC dba Fagron Sterile Service Compounding Pharmacy/Adulterated Drug ProductsCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
19 Dec 2024 JBRANDS LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
19 Dec 2024 Integra LifeSciences Corporation CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
18 Dec 2024 Sombra Cosmetics, Inc. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
18 Dec 2024 COFISA - Conservas de Peixe da Figueira, S.A. Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsHuman Foods Program — fda.gov ↗
18 Dec 2024 Elite Vapes Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
18 Dec 2024 Bhargava Phytolab Private Limited CGMP/Finished Pharmaceutical/API/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
18 Dec 2024 Jai Guruji LLC d/b/a Vape Marley Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
18 Dec 2024 E-liquid Brands, LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
18 Dec 2024 Vapezilla LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
18 Dec 2024 Chris Brown Vapes Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
18 Dec 2024 Vape Mania Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
18 Dec 2024 SJ Trading LTD d/b/a Cloud Chasers Club Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
18 Dec 2024 DK Global Enterprises LLC d/b/a I Love Vape LLC / Matrix Wholesaler LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
18 Dec 2024 Shindler Distribution Inc. d/b/a VapoRush Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
18 Dec 2024 Hologic, Inc. CGMP/QSR/Medical Devices/Adulterated/MisbrandedCenter for Devices and Radiological Health — fda.gov ↗
18 Dec 2024 Premium Fresh Growers LLC Foreign Supplier Verification Program (FSVP)Division of Southwest Imports — fda.gov ↗
17 Dec 2024 Brands International Corporation CGMP/Finished Pharmaceutical/Adulterated/Refusal to Allow InspectionCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
17 Dec 2024 Anne’s Daye Ltd dba Tampon Innovations Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceCenter for Devices and Radiological Health — fda.gov ↗
17 Dec 2024 Akron Formulations India Private Limited CGMP/Finished Pharmaceutical/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
16 Dec 2024 Skye Biologics Holdings LLC Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Center for Biologics Evaluation and Research (CBER) — fda.gov ↗
16 Dec 2024 Indoco Remedies Limited CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
12 Dec 2024 XO Biologix, LLC Unapproved New Drugs/AdulteratedCenter for Biologics Evaluation and Research (CBER) — fda.gov ↗
12 Dec 2024 INCELL Corporation LLC CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedCenter for Biologics Evaluation and Research (CBER) — fda.gov ↗
10 Dec 2024 Veronvy Unapproved New Drugs/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
09 Dec 2024 Xoran Technologies, LLC CGMP/QSR/Medical Devices/Adulterated/MisbrandedCenter for Devices and Radiological Health — fda.gov ↗
09 Dec 2024 Phillips Precision, Inc. CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
06 Dec 2024 Randox Laboratories Limited CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
04 Dec 2024 Candymar Produce Inc Foreign Supplier Verification Program (FSVP)Division of Southwest Imports — fda.gov ↗
26 Nov 2024 Duong Ha Processing Trading Seafood Company Limited Seafood HACCP/CGMP for Foods/AdulteratedHuman Foods Program — fda.gov ↗
18 Nov 2024 Breadbox Co. Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsHuman Foods Program — fda.gov ↗
14 Nov 2024 Salt City Baking Company, LLC CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedHuman Foods Program — fda.gov ↗
13 Nov 2024 Western Innovations, Inc. CGMP/Dietary Supplement/AdulteratedHuman Foods Program — fda.gov ↗
12 Nov 2024 Energetic Essences, LLC dba Pet Essences New Animal Drug/AdulteratedCenter for Veterinary Medicine — fda.gov ↗
12 Nov 2024 Nutrition Strength Ltd. New Animal Drug/AdulteratedCenter for Veterinary Medicine — fda.gov ↗
12 Nov 2024 HDFrenchies LLC dba Bully Baum New Animal Drug/AdulteratedCenter for Veterinary Medicine — fda.gov ↗
12 Nov 2024 Intermarket Industries Inc. dba Doc Ackerman Pet Products New Animal Drug/AdulteratedCenter for Veterinary Medicine — fda.gov ↗
12 Nov 2024 Veterinary Select Formula dba Allergic Pet New Animal Drug/AdulteratedCenter for Veterinary Medicine — fda.gov ↗
12 Nov 2024 Evolution Pets LLC New Animal Drug/AdulteratedCenter for Veterinary Medicine — fda.gov ↗
07 Nov 2024 Originitalia SRL CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
07 Nov 2024 Zhejiang Qimei Cosmetics Co., Ltd. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
06 Nov 2024 Unexo Lifesciences, Private Limited CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
06 Nov 2024 Eden F&C Co., Ltd Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsHuman Foods Program ✓ Closed out fda.gov ↗
06 Nov 2024 Daddy’s Vapor Distro Inc. Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
05 Nov 2024 Colgate-Palmolive/Tom's of Maine, Inc. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
05 Nov 2024 Multaler et Cie SAS CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
05 Nov 2024 Mariscos Procesados - CAMPRESA - S.A. Seafood HACCP/CGMP for Foods/AdulteratedHuman Foods Program ✓ Closed out fda.gov ↗
04 Nov 2024 Global Source Distribution, LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
01 Nov 2024 Frontier Biologics, LLC Unapproved New Drug/Unlicensed Biological Product ViolationsCenter for Biologics Evaluation and Research — fda.gov ↗
01 Nov 2024 Yeshua Bendito, C.A. Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsHuman Foods Program ✓ Closed out fda.gov ↗
01 Nov 2024 Owens & Minor, Inc. dba American Contract Systems, Inc. CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
31 Oct 2024 Liquid Nics LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
30 Oct 2024 BFL Metal Products Co., LTD Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Oct 2024 Nexus Smoke Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Oct 2024 Packs Pod Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Oct 2024 CSVAPE.COM LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Oct 2024 Vapes and Such Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Oct 2024 Funny Vapes Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Oct 2024 eCig Distributors, Inc. d/b/a eJuices.com Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Oct 2024 Armstrong County Memorial Hospital Institutional Review Board (IRB)Center for Drug Evaluation and Research (CDER) — fda.gov ↗
29 Oct 2024 Morevaping Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Oct 2024 Green Rush, LLC d/b/a XHALE CITY Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Oct 2024 North Disposable Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
28 Oct 2024 Rontis Hellas S.A. CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health ✓ Closed out fda.gov ↗
24 Oct 2024 Modern Smoking Solutions, LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
24 Oct 2024 Fancy Drops Beauty LLC Unapproved New Drugs/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
23 Oct 2024 MedOffice Saglik Endustri Anonim Sirketi CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
22 Oct 2024 Chongqing Tianrun Food Development Co., Ltd Low Acid Canned Food Regulation/AdulteratedHuman Foods Program — fda.gov ↗
22 Oct 2024 Ardent Animal Health, LLC Unapproved New Animal Drug ProductsCenter for Veterinary Medicine — fda.gov ↗
21 Oct 2024 Choice All Natural, Inc. dba Om Botanical CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
18 Oct 2024 Rolence Ent. Inc. CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
17 Oct 2024 Diora Kimya Sanayi ve Ticaret Limited Sirketi CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to RegisterCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
11 Oct 2024 Blackfly Investments, LLC dba Molecular® Testing Labs Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)Center for Biologics Evaluation and Research (CBER) — fda.gov ↗
10 Oct 2024 Soliteint Kozmetikai KFT CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
10 Oct 2024 Analytical Food Laboratories, Inc. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
10 Oct 2024 Future Best Trading Inc. Foreign Supplier Verification Program (FSVP)Division of West Coast Imports — fda.gov ↗
09 Oct 2024 OKC Vapes, LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
09 Oct 2024 Central Vapors and Central Vapors LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
02 Oct 2024 Omni Lens Pvt. Ltd. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to RegisterCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
01 Oct 2024 Amnio Technology, LLC Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Center for Biologics Evaluation and Research (CBER) — fda.gov ↗
01 Oct 2024 Paso Real Produce LLC Foreign Supplier Verification Program (FSVP)Division of Southwest Imports — fda.gov ↗
01 Oct 2024 Pinnacle Transplant Technologies, LLC Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Center for Biologics Evaluation and Research (CBER) — fda.gov ↗
30 Sep 2024 Miyajima Shoyu Co., Ltd. Acidified Foods/Emergency Permit Control/AdulteratedCenter for Food Safety and Applied Nutrition — fda.gov ↗
30 Sep 2024 Dalai Biotech Company Ltd Low Acid Canned Food Regulation/AdulteratedHuman Foods Program — fda.gov ↗
25 Sep 2024 Southeast Distro Inc. Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
20 Sep 2024 Azurity Pharmaceuticals, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugCenter for Drug Evaluation and Research (CDER) ✓ Closed out fda.gov ↗
12 Sep 2024 Quad Life USA Inc. Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 Mery Vape Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 Sweet TSV 1 d/b/a Sweet Vape Shop Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 Bugatti Vape, LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 Mr Fog Switch Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 MR FOG d/b/a MR FOG Officials Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 Beard Management Inc. d/b/a Beard Vape Co. d/b/a Lucky Bar Holdings, d/b/a Fifty Bar Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 Shenzhen Greensound High-Tech Co. Ltd. d/b/a ENVA Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 FUNCOOL Technology Co., Limited d/b/a RAZ Vape Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 Nomida.biz Unapproved New Drugs/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
12 Sep 2024 SS Vape Brands Inc. d/b/a Monster Vape Labs d/b/a The Monster Group Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 Exotic Wholesale LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
12 Sep 2024 Breeze Smoke Official Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
10 Sep 2024 Mid-Link Testing Company, Ltd Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)Center for Devices and Radiological Health — fda.gov ↗
10 Sep 2024 Aromas Para El Alma S.A. CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
10 Sep 2024 Sanitation & Environmental Technology Institute dba SDWH Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)Center for Devices and Radiological Health — fda.gov ↗
10 Sep 2024 Micro-X Ltd. CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
09 Sep 2024 EnviroServe Chemicals & Cleaners Ltd. CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
05 Sep 2024 Master Sales LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
03 Sep 2024 Avaria Health & Beauty Corp. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
30 Aug 2024 Root Bioscience Brands, LLC dba Naternal Unapproved New Drugs/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
29 Aug 2024 Orean Personal Care Ltd. CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
29 Aug 2024 Good Karma Cigar LLC Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Aug 2024 Zydus Lifesciences Limited CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER) ✓ Closed out fda.gov ↗
29 Aug 2024 Favorite Daughter, LLC d/b/a Phoenix Vapor Shop Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
29 Aug 2024 Vape On LLC d/b/a Imperial Vapor Co. Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
27 Aug 2024 Everymarket Inc. Unapproved New Drugs/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
27 Aug 2024 SoloVital Unapproved New Drugs/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
27 Aug 2024 MexHealth LLC d/b/a Al Natural E-Shop Unapproved New Drugs/MisbrandedCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
22 Aug 2024 California Veterinary Supply Unapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor SpeciesCenter for Veterinary Medicine — fda.gov ↗
22 Aug 2024 Parallel Direct LLC d/b/a The Magic Mist Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
20 Aug 2024 Julio R. Flamini, M.D./Clinical Integrative Research Center of Atlanta Clinical InvestigatorCenter for Drug Evaluation and Research (CDER) — fda.gov ↗
20 Aug 2024 Mother Stem Institute, Corp. Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Center for Biologics Evaluation and Research (CBER) — fda.gov ↗
19 Aug 2024 Kaylaan LLC CGMP/Finished Pharmaceuticals/AdulteratedDivision of Pharmaceutical Quality Operations I — fda.gov ↗
16 Aug 2024 Regenerative Processing Plant, LLC CGMP/Finished Pharmaceuticals/AdulteratedCenter for Biologics Evaluation and Research — fda.gov ↗
16 Aug 2024 EBCREATE Store Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
16 Aug 2024 Apollo Future Technology, Inc. Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
16 Aug 2024 Turning Point Brands, Inc. d/b/a VaporFi Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
16 Aug 2024 V3Beyond, Inc. d/b/a Beyond Vape Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
15 Aug 2024 Accupack Midwest, Inc. CGMP/Finished Pharmaceuticals/AdulteratedDivision of Pharmaceutical Quality Operations III — fda.gov ↗
14 Aug 2024 Graceleigh, Inc. dba Sammy’s Milk Food Labeling/MisbrandedDivision of Human and Animal Food Operations West V — fda.gov ↗
13 Aug 2024 Restorative Botanicals, LLC CGMP/Dietary Supplement/AdulteratedDivision of Human and Animal Food Operations West IV — fda.gov ↗
13 Aug 2024 Optikem International, Inc. CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health — fda.gov ↗
13 Aug 2024 Waiakea Bottling Inc. CGMP/Processing & Bottling of Bottled Drinking Water Regulations/AdulteratedDivision of Human and Animal Food Operations West V — fda.gov ↗
12 Aug 2024 Greco Gas, Inc. CGMP/Finished Pharmaceuticals/AdulteratedOffice of Pharmaceutical Quality — fda.gov ↗
08 Aug 2024 Shenzhen Moyeah Intelligent Life Technology Co. Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceCenter for Devices and Radiological Health — fda.gov ↗
07 Aug 2024 Natures Pillows, Inc. and Top Dog Direct, LLC Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceCenter for Devices and Radiological Health — fda.gov ↗
07 Aug 2024 Adventure Innovations LLC Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceCenter for Devices and Radiological Health — fda.gov ↗
07 Aug 2024 LEEL Tech Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceCenter for Devices and Radiological Health — fda.gov ↗
07 Aug 2024 J. Moniz Company Inc. Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsDivision of Northeast Imports — fda.gov ↗
06 Aug 2024 Wittman Pharma, Inc. CGMP/Finished Pharmaceuticals/AdulteratedDivision of Pharmaceutical Quality Operations II — fda.gov ↗
05 Aug 2024 Anglo Freight USA Inc. Foreign Supplier Verification Program (FSVP)Division of Northern Border Imports — fda.gov ↗
01 Aug 2024 Dasada Group LLC Foreign Supplier Verification Program (FSVP)Division of Southwest Imports — fda.gov ↗
29 Jul 2024 1 Stop Chicken Health Shop Unapproved New Animal Drug ProductsCenter for Veterinary Medicine — fda.gov ↗
24 Jul 2024 Aerosol and Liquid Packaging, Inc. CGMP/Finished Pharmaceuticals/AdulteratedDivision of Pharmaceutical Quality Operations I — fda.gov ↗
24 Jul 2024 Warbucks Seafood NY LLC Foreign Supplier Verification Program (FSVP)Division of Northeast Imports ✓ Closed out fda.gov ↗
17 Jul 2024 TJA Health, LLC CGMP/Finished Pharmaceuticals/AdulteratedDivision of Pharmaceutical Quality Operations III — fda.gov ↗
28 Jun 2024 Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Center for Biologics Evaluation and Research (CBER) — fda.gov ↗
24 Jun 2024 Ozempen.com Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetCenter for Drug Evaluation and Research | CDER — fda.gov ↗
04 Jun 2024 Fancystage Unipessoal, LDA CGMP/Finished Pharmaceuticals/Adulterated/MisbrandedCenter for Drug Evaluation and Research | CDER — fda.gov ↗
03 Jun 2024 Top Health Manufacturing, LLC CGMP/Dietary Supplement/AdulteratedDivision of Human and Animal Food Operations West IV — fda.gov ↗
31 May 2024 Rongcheng Jiayuan Food Co., Ltd Seafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsCenter for Food Safety and Applied Nutrition (CFSAN) ✓ Closed out fda.gov ↗
30 May 2024 Smoke Shop Direct Dist, Inc. Family Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedCenter for Tobacco Products — fda.gov ↗
16 May 2024 Swity d.o.o. Acidified Foods/Emergency Permit Control/Adulterated/MisbrandedCenter for Food Safety and Applied Nutrition ✓ Closed out fda.gov ↗
16 May 2024 All Things Bunnies, Inc. Unapproved New Animal Drug/AdulteratedCenter for Veterinary Medicine — fda.gov ↗