FDA Inspection
Actavis Pharma Development Centre Private LtdActavis Pharma Development Centre Private Ltd – FDA Inspection, Jul 11, 2023
Record Details
This FDA Inspection record concerns Actavis Pharma Development Centre Private Ltd, with an inspection on July 11, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f4b50a47-352d-4c79-a450-f322b88b6b1a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210944
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Actavis Pharma Development Centre Private Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 5, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 20, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Actavis Pharma Development Centre Private Ltd
- FDA Inspection 1025933 - 2017-09-21
- FDA Inspection 909974 - 2014-12-05
- FDA Inspection 752923 - 2011-10-20
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