FDA Inspection
Precision Equine, LLCPrecision Equine, LLC – FDA Inspection, Sep 22, 2023
Record Details
This FDA Inspection record concerns Precision Equine, LLC, with an inspection on September 22, 2023, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 055696a6-48de-42fd-973d-6047ae041906
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1220015
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
- Enforcement
- Untitled Letter
FDA Citations
16- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
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Other FDA inspections of Precision Equine, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2009 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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