FDA Inspection 1086628 — Par Health USA, LLC
The FDA completed an inspection of Par Health USA, LLC on Apr 15, 2019 in Rochester, MI. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 15, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rochester, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |