FDA Inspection
Hoof Health, LLCHoof Health, LLC – FDA Inspection, Sep 26, 2018
Record Details
This FDA Inspection record concerns Hoof Health, LLC, with an inspection on September 26, 2018, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 5ab0495f-283f-446f-bab1-79449d543208
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066790
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of Hoof Health, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 7, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 11, 2014 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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