FDA Inspection 1029169 — Aero All-Gas Company
The FDA completed an inspection of Aero All-Gas Company on Oct 19, 2017 in Hartford, CT. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 19, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hartford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |