FDA Inspection
Sun Pharmaceutical Medicare LimitedSun Pharmaceutical Medicare Limited – FDA Inspection, Jul 13, 2023
Record Details
This FDA Inspection record concerns Sun Pharmaceutical Medicare Limited, with an inspection on July 13, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9be2a665-7c65-442b-91dd-1a12afa5bc54
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210949
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Sun Pharmaceutical Medicare Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2025 | Not classified | Office of Inspections and Investigations | |
| February 27, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 5, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 17, 2017 | Not classified | Office of Inspections and Investigations | |
| August 11, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Sun Pharmaceutical Medicare Limited
- FDA Inspection 1288660 - 2025-09-19
- FDA Inspection 1231121 - 2024-02-27
- FDA Inspection 1078834 - 2019-02-05
- FDA Inspection 1037571 - 2017-11-17
- FDA Inspection 1025918 - 2017-08-11
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