FDA Inspection 859014 — University Of Iowa Pharmaceuticals
The FDA completed an inspection of University Of Iowa Pharmaceuticals on Dec 13, 2013 in Iowa City, IA. 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). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2013
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Iowa City, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |