FDA Inspection 775601 — Abbott Vascular
The FDA completed an inspection of Abbott Vascular on Mar 12, 2012 in Barceloneta, PR. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Barceloneta, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4208 | 21 CFR 806.20(a) | Records not kept |