FDA Inspection
Emcure Pharmaceuticals LimitedEmcure Pharmaceuticals Limited – FDA Inspection, Feb 16, 2023
Record Details
This FDA Inspection record concerns Emcure Pharmaceuticals Limited, with an inspection on February 16, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- February 16, 2023
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ID · 300be940-a9ca-4bac-9df6-1cad915df6d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198647
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Emcure Pharmaceuticals Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| July 8, 2025 | Not classified | Office of Inspections and Investigations | |
| April 5, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 17, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 1, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Emcure Pharmaceuticals Limited
- FDA Inspection 1317132 - 2026-05-15
- FDA Inspection 1278622 - 2025-07-08
- FDA Inspection 1235038 - 2024-04-05
- FDA Inspection 1140812 - 2020-03-17
- FDA Inspection 1082800 - 2019-02-01
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