FDA Inspection
Alembic Pharmaceuticals LimitedAlembic Pharmaceuticals Limited – FDA Inspection, Mar 8, 2024
Record Details
This FDA Inspection record concerns Alembic Pharmaceuticals Limited, with an inspection on March 8, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0a8e3bc4-96ca-4680-9822-03aa93ccf64d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1232189
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Alembic Pharmaceuticals Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Alembic Pharmaceuticals Limited
- FDA Inspection 1099355 - 2019-06-28
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