FDA Inspection 1050957 — Actavis LLC
The FDA completed an inspection of Actavis LLC on May 7, 2018 in Edison, NJ. 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 7, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1498 | 21 CFR 211.122(b) | Labeling and packaging improperly approved/released |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |