FDA Inspection 823997 — AN-FO Pacifica
The FDA completed an inspection of AN-FO Pacifica on May 2, 2013 in Visalia, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 2, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Visalia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |