FDA Inspection 616289 — Epien Medical, Inc
The FDA completed an inspection of Epien Medical, Inc on Sep 29, 2009 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- White Bear Lake, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |