FDA Inspection 851401 — ENDO USA, Inc
The FDA completed an inspection of ENDO USA, Inc on Oct 28, 2013 in Rye, NY. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 28, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rye, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 6823 | 21 CFR 314.80(c) | Failure by applicant to report ADE |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |