FDA Inspection 911360 — Bard Peripheral Vascular Inc
The FDA completed an inspection of Bard Peripheral Vascular Inc on January 5, 2015 in Tempe, AZ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 5, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tempe, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 735 | 21 CFR 803.50(b)(3) | Conducting an Investigation |