FDA Inspection
Actavis LLCActavis LLC – FDA Inspection, May 7, 2018
Record Details
This FDA Inspection record concerns Actavis LLC, with an inspection on May 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 38794933-e9f1-46d8-8f94-423a0137a9e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050957
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.84(c)(2)Containers sampled so as to prevent contamination
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.122(b)Labeling and packaging improperly approved/released
- 21 CFR 211.42(c)(7)Quarantined Drug Products Area
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Actavis LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 22, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 8, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 7, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 29, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Actavis LLC
- FDA Inspection 1256490 - 2024-11-22
- FDA Inspection 1100659 - 2019-08-08
- FDA Inspection 978483 - 2016-07-07
- FDA Inspection 854136 - 2013-10-29
- FDA Inspection 764993 - 2012-01-27
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