FDA Inspection 1073560 — Epien Medical, Inc
The FDA completed an inspection of Epien Medical, Inc on Dec 6, 2018 in White Bear Lake, 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 6, 2018
- Fiscal Year
- 2019
- 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 |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |