FDA Inspection 671689 — Abbott Vascular, Inc.
The FDA completed an inspection of Abbott Vascular, Inc. on August 30, 2010 in Redwood City, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Redwood City, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |