FDA Inspection
Huvepharma, Inc.Huvepharma, Inc. – FDA Inspection, Apr 23, 2019
Record Details
This FDA Inspection record concerns Huvepharma, Inc., with an inspection on April 23, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 53019d59-7c8e-48ec-9eaf-15e782c993c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087819
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.160(b)(1)Sampling and testing procedures described
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Other FDA inspections of Huvepharma, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| November 23, 2016 | VAI | Denver District Office | Pre-Approval Eval. of Animal Drugs and Food Additives |
| December 4, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 12, 2013 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 21, 2012 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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