FDA Inspection 859099 — Epien Medical, Inc
The FDA completed an inspection of Epien Medical, Inc on December 11, 2013 in White Bear Lake, 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
- December 11, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- White Bear Lake, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |