FDA Inspection 971802 — Wickliffe Pharmaceutical Inc
The FDA completed an inspection of Wickliffe Pharmaceutical Inc on April 7, 2016 in Lexington, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 7, 2016
- Fiscal Year
- 2016
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Lexington, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |