FDA Inspection 1050973 — University Of Iowa Pharmaceuticals
The FDA completed an inspection of University Of Iowa Pharmaceuticals on May 4, 2018 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
- May 4, 2018
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Iowa City, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |