FDA Inspection
Alkem Laboratories LimitedAlkem Laboratories Limited – FDA Inspection, Mar 10, 2017
Record Details
This FDA Inspection record concerns Alkem Laboratories Limited, with an inspection on March 10, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 97135be8-da4f-449a-9f76-3001d172fd0b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007598
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Alkem Laboratories Limited
11| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 26, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2019 | Not classified | Office of Inspections and Investigations | |
| May 17, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alkem Laboratories Limited
- FDA Inspection 1233569 - 2024-03-27
- FDA Inspection 1118336 - 2020-02-21
- FDA Inspection 1140381 - 2019-11-26
- FDA Inspection 1105480 - 2019-08-23
- FDA Inspection 1089865 - 2019-05-17
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