FDA Inspection 564161 — Boston Scientific Corp.
The FDA completed an inspection of Boston Scientific Corp. on Feb 12, 2009 in Coventry, RI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 12, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Coventry, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3271 | 21 CFR 820.80(d) | Quarantine of finished devices |
| 3696 | 21 CFR 820.100(b) | Documentation |