FDA Inspection
Alkem Laboratories LimitedAlkem Laboratories Limited – FDA Inspection, May 1, 2026
Record Details
This FDA Inspection record concerns Alkem Laboratories Limited, with an inspection on May 1, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 68f3461d-9e61-4de7-a8e4-50bd68498a2b
Inspection Facts
- Inspection number
- 1313924
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
Other FDA inspections of Alkem Laboratories Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 18, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 25, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alkem Laboratories Limited
- FDA Inspection 1106347 - 2019-08-30
- FDA Inspection 1080442 - 2019-01-18
- FDA Inspection 1046054 - 2018-03-27
- FDA Inspection 989408 - 2016-09-29
- FDA Inspection 854604 - 2013-10-25
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