FDA Inspection 1220015 — Precision Equine, LLC
The FDA completed an inspection of Precision Equine, LLC on September 22, 2023 in Bakersfield, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bakersfield, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4576 | 21 CFR 211.192 | No written record of investigation |