FDA Inspection
Alkem Laboratories LimitedAlkem Laboratories Limited – FDA Inspection, Mar 27, 2018
Record Details
This FDA Inspection record concerns Alkem Laboratories Limited, with an inspection on March 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2e825427-e371-45e0-88c1-25338be5923f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046054
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.176Failing to test for penicillin cross-contamination
- 21 CFR 211.110(a)(1)Tablet or capsule weight variation
- 21 CFR 211.22(a)Approve or reject components, products
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Other FDA inspections of Alkem Laboratories Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2026 | Not classified | Office of Inspections and Investigations | |
| 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 |
| 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 1106347 - 2019-08-30
- FDA Inspection 1080442 - 2019-01-18
- FDA Inspection 989408 - 2016-09-29
- FDA Inspection 854604 - 2013-10-25
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