FDA Inspection 1084607 — St. Jude Medical, Atrial Fibrillation Division, Inc.
The FDA completed an inspection of St. Jude Medical, Atrial Fibrillation Division, Inc. on March 29, 2019 in Saint Paul, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Paul, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |