FDA Inspection 1230375 — Actavis Laboratories UT, Inc.
The FDA completed an inspection of Actavis Laboratories UT, Inc. on Mar 19, 2024 in Salt Lake City, UT. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 19, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |