FDA Inspection 651144 — St Jude Medical Inc
The FDA completed an inspection of St Jude Medical Inc on Mar 25, 2010 in Saint Paul, MN. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 25, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Paul, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2279 | 21 CFR 820.20(b)(2) | Resources |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3379 | 21 CFR 820.198(e)(5) | Nature and details of complaint |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |