FDA Inspection
AN-FO PacificaAN-FO Pacifica – FDA Inspection, May 2, 2013
Record Details
This FDA Inspection record concerns AN-FO Pacifica, with an inspection on May 2, 2013, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- AN-FO Pacifica
- Inspection Date
- May 2, 2013
- Product Type
- Veterinary
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ID · d0007e27-c4c6-4aa9-b82a-51915ec9da58
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823997
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of AN-FO Pacifica
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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