FDA Inspection 1142532 — Actavis Laboratories FL, Inc.
The FDA completed an inspection of Actavis Laboratories FL, Inc. on May 25, 2021 in Davie, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 25, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Davie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |