FDA Inspection
Alembic Pharmaceuticals LimitedAlembic Pharmaceuticals Limited – FDA Inspection, Sep 20, 2019
Record Details
This FDA Inspection record concerns Alembic Pharmaceuticals Limited, with an inspection on September 20, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · a893a117-d22a-447a-ab79-71a21e483d09
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102336
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Alembic Pharmaceuticals Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 8, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 8, 2019 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| October 19, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Alembic Pharmaceuticals Limited
- FDA Inspection 1203306 - 2023-03-10
- FDA Inspection 1118669 - 2020-01-08
- FDA Inspection 1078542 - 2019-02-08
- FDA Inspection 1074508 - 2018-10-19
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