FDA Inspection
Huvepharma, Inc.Huvepharma, Inc. – FDA Inspection, Jul 14, 2017
Record Details
This FDA Inspection record concerns Huvepharma, Inc., with an inspection on July 14, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 47b6cc03-5c74-4099-a349-d69a357e49e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018414
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Huvepharma, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2019 | 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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