FDA Inspection 668703 — Pharmgate Inc.
The FDA completed an inspection of Pharmgate Inc. on June 21, 2010 in Omaha, NE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 21, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2352 | 21 CFR 226.58(a) | Specifications, test procedures - components |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4416 | 21 CFR 211.204 | Reprocessed returned drug products |