FDA Inspection
Huvepharma, Inc.Huvepharma, Inc. – FDA Inspection, Nov 23, 2016
Record Details
This FDA Inspection record concerns Huvepharma, Inc., with an inspection on November 23, 2016, issued by the Denver District Office, covering animal drugs & feeds.
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ID · 33f03bd7-1aff-47a3-9aa3-ffccc12d8a99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998811
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(b)input/output verification
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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 |
| July 14, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| 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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