FDA Inspection
Actavis Laboratories FL, Inc.Actavis Laboratories FL, Inc. – FDA Inspection, Jul 19, 2018
Record Details
This FDA Inspection record concerns Actavis Laboratories FL, Inc., with an inspection on July 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Chiaochun J. Wang (Issuing Officer)
- Fabian N. Chaparro-rodriguez (Issuing Officer)
- Ileana Barreto-Pettit (Issuing Officer)
- Jennifer L. Huntington (FDA Associated Person)
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ID · 3f37bb61-9c39-496d-b2dc-e5d4e71db4a5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1059371
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
10- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.68(b)Computer control of master formula records
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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 |
| May 25, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 17, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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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