FDA Inspection 1216813 — Prime Enterprises LLC
The FDA completed an inspection of Prime Enterprises LLC on Sep 1, 2023 in Hialeah, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 1, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Hialeah, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1456 | 21 CFR 211.115(b) | Reprocessing/quality control unit |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4576 | 21 CFR 211.192 | No written record of investigation |