FDA Inspection 809209 — ENDO USA, Inc
The FDA completed an inspection of ENDO USA, Inc on December 7, 2012 in Rye, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 7, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rye, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |