FDA Inspection 792524 — Aero Compressed Gases, Inc.
The FDA completed an inspection of Aero Compressed Gases, Inc. on Jul 27, 2012 in Milwaukee, WI. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 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 |