792524
Aero Compressed Gases, Inc. — FEI 3003420258
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 27, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Milwaukee, WI (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |