FDA Inspection
Boston Scientific CorporationBoston Scientific Corporation – FDA Inspection, Feb 24, 2014
Record Details
This FDA Inspection record concerns Boston Scientific Corporation, with an inspection on February 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 24, 2014
- Product Type
- Devices
View Company Profile
ID · 718541cc-3044-4236-8a4f-16ab15fcfc50
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 868462
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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 |
| January 29, 2016 | VAI | 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 958603 - 2016-01-29
- FDA Inspection 828801 - 2013-04-25
- FDA Inspection 818398 - 2013-02-15
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