FDA Inspection
Boston Scientific CorporationBoston Scientific Corporation – FDA Inspection, Dec 14, 2016
Record Details
This FDA Inspection record concerns Boston Scientific Corporation, with an inspection on December 14, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a0e3ece7-ceba-41dd-818e-e56deea1b755
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 996922
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
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