FDA Inspection
Actavis Laboratories FL, Inc.Actavis Laboratories FL, Inc. – FDA Inspection, May 25, 2021
Record Details
This FDA Inspection record concerns Actavis Laboratories FL, Inc., with an inspection on May 25, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 25, 2021
- Product Type
- Drugs
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ID · 70e55557-fdb4-44c7-894c-3606fbe8789a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1142532
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Actavis Laboratories FL, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| January 17, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 19, 2018 | OAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| November 28, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 15, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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