FDA Inspection 552978 — Boston Scientific Corp.
The FDA completed an inspection of Boston Scientific Corp. on Dec 12, 2008 in Coventry, RI. 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)
- End Date
- Dec 12, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Coventry, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3271 | 21 CFR 820.80(d) | Quarantine of finished devices |
| 3302 | 21 CFR 820.100(a)(3) | Identifying corrective & preventive actions |
| 3671 | 21 CFR 820.25(a) | Personnel |