671171
Alliance Packaging Group, Inc. — FEI 3003315832
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 21, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saukville, WI (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |