FDA Inspection
Alkem Laboratories LimitedAlkem Laboratories Limited – FDA Inspection, Aug 30, 2019
Record Details
This FDA Inspection record concerns Alkem Laboratories Limited, with an inspection on August 30, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 521a2174-decc-44a9-80b4-94e8507a169a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1106347
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Alkem Laboratories Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2026 | Not classified | Office of Inspections and Investigations | |
| 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 1313924 - 2026-05-01
- 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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