FDA Inspection 973827 — Boston Scientific Corporation
The FDA completed an inspection of Boston Scientific Corporation on Feb 24, 2016 in Minneapolis, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 24, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |