FDA Inspection 900144 — Actavis Laboratories UT, Inc.
The FDA completed an inspection of Actavis Laboratories UT, Inc. on Oct 17, 2014 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 17, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4576 | 21 CFR 211.192 | No written record of investigation |