FDA Inspection 1287690 — Par Health USA, LLC
The FDA completed an inspection of Par Health USA, LLC on Oct 20, 2025 in Rochester, MI. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 20, 2025
- Fiscal Year
- 2026
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Rochester, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |