FDA Inspection 811693 — Aurora Pharmaceutical, Inc.
The FDA completed an inspection of Aurora Pharmaceutical, Inc. on Nov 27, 2012 in Northfield, MN. 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). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 27, 2012
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Northfield, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |