FDA Inspection 1282698 — Actavis Laboratories UT, Inc.
The FDA completed an inspection of Actavis Laboratories UT, Inc. on September 19, 2025 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 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 |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |