FDA Inspection 628953 — Precision Equine, LLC
The FDA completed an inspection of Precision Equine, LLC on November 18, 2009 in Bakersfield, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 18, 2009
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bakersfield, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4115 | 21 CFR 530.13(a) | Compounding from bulk drugs |
| 4118 | 21 CFR 530.13(b)(3) | Compounding outside of scope of professional practice |
| 4119 | 21 CFR 530.13(b)(4) | Compounding procedures and processes not followed |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |