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Shilpa Medicare — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Shilpa Medicare (NSE: SHILPAMED, BSE: 530549), from US FDA records and exchange filings.
66
Compliance score (5 years) · how
5
USFDA-inspected plants on record
0
OAI classifications (5y)
1
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified NAI — 14 Mar 2025 (Chicksugur, Raichur plant). Source: FDA Data Dashboard.
USFDA events by year
2021
2023
2024
2025
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Chicksugur, Raichur Shilpa Pharma Lifesciences Limited |
3007197995 | NAI | 14 Mar 2025 | |
| Deosugur Shilpa Pharma Lifesciences Limited |
3025560903 | VAI | 07 Mar 2025 | |
| Dabaspet, Bengaluru Shilpa Medicare Limited |
3018694237 | VAI | 30 Oct 2024 | |
| Hyderbad Shilpa Medicare Limited |
3030542761 | NAI | 01 Mar 2024 | |
| Hyderabad Shilpa Medicare Limited |
3019773458 | VAI | 10 Mar 2023 |
Full USFDA timeline
14 Mar 2025
NAI — clean
USFDA inspection classified NAI
Chicksugur, Raichur · FEI 3007197995 · Shilpa Pharma Lifesciences Limited, Chicksugur, Raichur — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
07 Mar 2025
VAI — minor issues
USFDA inspection classified VAI
Deosugur · FEI 3025560903 · Shilpa Pharma Lifesciences Limited, Deosugur — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
30 Oct 2024
Form 483
Form 483: 2 observations
Dabaspet, Bengaluru · FEI 3018694237 · Calibration/Inspection/Checking not done; Signature and checking of records -- 2 persons
Source: FDA Data Dashboard (citations) ↗
30 Oct 2024
VAI — minor issues
USFDA inspection classified VAI
Dabaspet, Bengaluru · FEI 3018694237 · Shilpa Medicare Limited, Dabaspet, Bengaluru — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
01 Mar 2024
NAI — clean
USFDA inspection classified NAI
Hyderbad · FEI 3030542761 · Shilpa Medicare Limited, Hyderbad — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
10 Mar 2023
VAI — minor issues
USFDA inspection classified VAI
Hyderabad · FEI 3019773458 · Shilpa Medicare Limited, Hyderabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
16 Feb 2021
Import alert
Added to FDA import alert 66-40
Shilpa Medicare Limited, Plot No. S20 to S26, Pharmaceutical Formulations SEZ, TSIIC Green Industrial Park, Polepally (Village), Jadcherla, Mahabubnagar District, Telangana INDIA
Source: FDA import alerts ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/shilpa