647613
Aero All-Gas Company — FEI 1216326
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 24, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hartford, CT (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |