FDA Inspection
Boston Scientific CorporationBoston Scientific Corporation – FDA Inspection, Apr 16, 2012
Record Details
This FDA Inspection record concerns Boston Scientific Corporation, with an inspection on April 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 16, 2012
- Product Type
- Devices
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ID · 68504a8c-c476-48eb-8469-47754d434e19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781058
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Boston Scientific Corporation
20| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2025 | OAI | Minneapolis District Office | Compliance: Medical Devices |
| August 1, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 29, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 15, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Boston Scientific Corporation
- FDA Inspection 1257844 - 2025-04-07
- FDA Inspection 1215054 - 2023-08-01
- FDA Inspection 1157921 - 2021-10-29
- FDA Inspection 1066347 - 2018-07-31
- FDA Inspection 1032428 - 2017-11-15
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