616289
Epien Medical, Inc — FEI 3003428492
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 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 |