FDA Inspection 1020627 — Provimi North America, LLC
The FDA completed an inspection of Provimi North America, LLC on Aug 7, 2017 in Fremont, NE. 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
- Aug 7, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Fremont, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1638 | 21 CFR 225.42(b)(5) | Elements of receipt record |
| 1744 | 21 CFR 225.42(b)(6) | Daily inventory record kept |
| 1792 | 21 CFR 225.42(b)(7) | Discrepancies |
| 1811 | 21 CFR 225.58(b)(1) | Three assays per year |
| 1821 | 21 CFR 225.58(b)(1) | First batch assay |