FDA Inspection
Boston Scientific CorporationBoston Scientific Corporation – FDA Inspection, Jan 7, 2010
Record Details
This FDA Inspection record concerns Boston Scientific Corporation, with an inspection on January 7, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 7, 2010
- Product Type
- Devices
View Company Profile
ID · 226a4332-2d3e-4deb-a640-1191699ed6d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 637993
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boston Scientific Corporation
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 28, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 20, 2017 | Not classified | San Francisco District Office | |
| February 7, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 20, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Boston Scientific Corporation
- FDA Inspection 1106866 - 2019-09-25
- FDA Inspection 1074747 - 2018-11-28
- FDA Inspection 1048056 - 2017-10-20
- FDA Inspection 1000904 - 2017-02-07
- FDA Inspection 919207 - 2015-03-20
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