FDA Inspection 782613 — Ulmer Pharmacal Co
The FDA completed an inspection of Ulmer Pharmacal Co on May 17, 2012 in Park Rapids, MN. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 17, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Park Rapids, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |