FDA Inspection
Alkem Laboratories LimitedAlkem Laboratories Limited – FDA Inspection, May 17, 2019
Record Details
This FDA Inspection record concerns Alkem Laboratories Limited, with an inspection on May 17, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d7f7b6fa-ac14-499f-a64d-10cca500b11f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089865
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)(2)Acceptance of in-process materials
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 | |
| 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 1140381 - 2019-11-26
- FDA Inspection 1105480 - 2019-08-23
- FDA Inspection 1072545 - 2018-08-10
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