FDA Inspection
Boston Scientific CorporationBoston Scientific Corporation – FDA Inspection, Jan 29, 2016
Record Details
This FDA Inspection record concerns Boston Scientific Corporation, with an inspection on January 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 29, 2016
- Product Type
- Devices
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ID · 2b4b8339-b086-4055-86a0-636f3e6a3a52
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 958603
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boston Scientific Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 27, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 25, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 15, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Boston Scientific Corporation
- FDA Inspection 1036678 - 2017-12-11
- FDA Inspection 1018598 - 2017-06-27
- FDA Inspection 868462 - 2014-02-24
- FDA Inspection 828801 - 2013-04-25
- FDA Inspection 818398 - 2013-02-15
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