FDA Inspection
Boston Scientific CorporationBoston Scientific Corporation – FDA Inspection, Oct 9, 2014
Record Details
This FDA Inspection record concerns Boston Scientific Corporation, with an inspection on October 9, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 9, 2014
- Product Type
- Devices
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ID · 3971b1ea-179e-49ad-8d36-c9db9f732b7e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 903335
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Boston Scientific Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 21, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Boston Scientific Corporation
- FDA Inspection 715416 - 2011-03-18
- FDA Inspection 611935 - 2009-08-21
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