FDA Inspection
Alkem Laboratories LimitedAlkem Laboratories Limited – FDA Inspection, Nov 26, 2019
Record Details
This FDA Inspection record concerns Alkem Laboratories Limited, with an inspection on November 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Alkem Laboratories Limited
- Inspection Date
- November 26, 2019
- Product Type
- Drugs
View Company Profile
ID · 12a07ed8-d60e-460e-9c9c-19a7dfad6aae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1140381
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
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 |
| August 23, 2019 | Not classified | Office of Inspections and Investigations | |
| May 17, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 10, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Alkem Laboratories Limited
- FDA Inspection 1233569 - 2024-03-27
- FDA Inspection 1118336 - 2020-02-21
- FDA Inspection 1105480 - 2019-08-23
- FDA Inspection 1089865 - 2019-05-17
- FDA Inspection 1072545 - 2018-08-10
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