FDA Inspection
Alembic Pharmaceuticals LimitedAlembic Pharmaceuticals Limited – FDA Inspection, Mar 24, 2023
Record Details
This FDA Inspection record concerns Alembic Pharmaceuticals Limited, with an inspection on March 24, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0ed75c70-4530-4b68-a32a-1e3ca510c4ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1201100
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.22(c)Approve or reject procedures or specs
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Other FDA inspections of Alembic Pharmaceuticals Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2026 | Not classified | Office of Inspections and Investigations |
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