FDA Inspection 710971 — Zydus Pharmaceuticals (USA) Inc
The FDA completed an inspection of Zydus Pharmaceuticals (USA) Inc on February 22, 2011 in Pennington, NJ. 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
- February 22, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Pennington, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |