FDA Inspection 1002791 — ABS Corporation
The FDA completed an inspection of ABS Corporation on February 27, 2017 in Omaha, NE. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 27, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- 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 |