FDA Inspection
Hoof Health, LLCHoof Health, LLC – FDA Inspection, Jan 7, 2016
Record Details
This FDA Inspection record concerns Hoof Health, LLC, with an inspection on January 7, 2016, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Hoof Health, LLC
- Inspection Date
- January 7, 2016
- Product Type
- Veterinary
View Company Profile
ID · cb926ccd-48c5-470f-94d6-c6b9a3e03a48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 957296
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
7- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(a)Procedures To Be in Writing
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hoof Health, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2018 | 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 |
Other documents for Hoof Health, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.