FDA Inspection
Alkem Laboratories LimitedAlkem Laboratories Limited – FDA Inspection, Dec 9, 2016
Record Details
This FDA Inspection record concerns Alkem Laboratories Limited, with an inspection on December 9, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 94a4c29c-0c6f-497e-a3f2-6e1aa9e35a44
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998189
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Alkem Laboratories Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 23, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alkem Laboratories Limited
- FDA Inspection 1206190 - 2023-04-07
- FDA Inspection 856244 - 2013-11-23
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