FDA Inspection 646942 — St. Jude Medical
The FDA completed an inspection of St. Jude Medical on January 22, 2010 in Minnetonka, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Minnetonka, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2279 | 21 CFR 820.20(b)(2) | Resources |
| 3693 | 21 CFR 820.100(a)(5) | Implementing changes |
| 3694 | 21 CFR 820.100(a)(6) | Dissemination of problem information |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |