FDA Inspection 1002791 — ABS Corporation
The FDA completed an inspection of ABS Corporation on Feb 27, 2017 in Omaha, NE. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 27, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |