FDA Inspection
Shilpa Medicare LimitedShilpa Medicare Limited – FDA Inspection, Mar 10, 2023
Record Details
This FDA Inspection record concerns Shilpa Medicare Limited, with an inspection on March 10, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9391676a-8df7-457f-a6e9-67c198678aa7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1202016
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.160(a)Following/documenting laboratory controls
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Other FDA inspections of Shilpa Medicare Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
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