FDA Inspection
Emcure Pharmaceuticals LimitedEmcure Pharmaceuticals Limited – FDA Inspection, May 15, 2026
Record Details
This FDA Inspection record concerns Emcure Pharmaceuticals Limited, with an inspection on May 15, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 4549cfb8-2e9f-4ad6-b392-bc84338e3a0a
Inspection Facts
- Inspection number
- 1317132
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.63Equipment Design, Size and Location
- 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 |
|---|---|---|---|
| July 8, 2025 | Not classified | Office of Inspections and Investigations | |
| April 5, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 16, 2023 | VAI | Office of Inspections and Investigations | |
| 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 1278622 - 2025-07-08
- FDA Inspection 1235038 - 2024-04-05
- FDA Inspection 1198647 - 2023-02-16
- FDA Inspection 1140812 - 2020-03-17
- FDA Inspection 1082800 - 2019-02-01
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