791562
Ulmer Pharmacal Co — FEI 2110701
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 11, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Park Rapids, MN (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |