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Intas Pharmaceuticals (unlisted) — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Intas Pharmaceuticals (unlisted), from US FDA records and exchange filings.
3
Compliance score (5 years) · how
3
USFDA-inspected plants on record
2
OAI classifications (5y)
1
Form 483s on record (5y)
1
Open warning letters
Latest USFDA record: USFDA inspection classified OAI — 16 Sep 2025 (Selaqui plant). Source: FDA Data Dashboard.
USFDA events by year
2022
2023
2024
2025
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
Full USFDA timeline
16 Sep 2025
OAI — serious issues
USFDA inspection classified OAI
Selaqui · FEI 3005890633 · Intas Pharmaceuticals Ltd., Selaqui — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
12 Jul 2024
NAI — clean
USFDA inspection classified NAI
Ahmedabad · FEI 3003157498 · Intas Pharmaceuticals Limited, Ahmedabad — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
21 Nov 2023
Warning letter
USFDA warning letter
Intas Pharmaceuticals Limited — CGMP/Finished Pharmaceuticals/Adulterated
Source: FDA warning letters ↗
14 Nov 2023
Import alert
Added to FDA import alert 66-40
Intas Pharmaceuticals Limited, Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi, Sarkhej-Bavla Highway, Taluka-Sanand, Matoda, Ahmedabad, Gujarat INDIA
Source: FDA import alerts ↗
01 Jun 2023
Import alert
Added to FDA import alert 66-40
Intas Pharmaceuticals Limited, Pharmez Plot No 5-14, Near Village Matoda; Sarkhej-Bavla Highway No 8-A, Sanand, Gujarat INDIA
Source: FDA import alerts ↗
02 Dec 2022
Form 483
Form 483: 2 observations
Sanand · FEI 3004011473 · Complete test data included in records; Results not used for expiration dates, storage cond.
Source: FDA Data Dashboard (citations) ↗
02 Dec 2022
OAI — serious issues
USFDA inspection classified OAI
Sanand · FEI 3004011473 · Intas Pharmaceuticals Limited, Sanand — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/intas