FDA Inspection
Boston Scientific CorporationBoston Scientific Corporation – FDA Inspection, Nov 26, 2024
Record Details
This FDA Inspection record concerns Boston Scientific Corporation, with an inspection on November 26, 2024, issued by the New England District Office, covering medical devices & rad health.
- Inspection Date
- November 26, 2024
- Product Type
- Medical Devices & Rad Health
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ID · eefde949-c3da-46ba-b8c3-50e3a653a7d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1246067
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 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
13| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2023 | Not classified | New England District Office | |
| June 7, 2019 | Not classified | New England District Office | |
| May 29, 2019 | Not classified | New England District Office | |
| October 31, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 20, 2018 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Boston Scientific Corporation
- FDA Inspection 1196120 - 2023-01-13
- FDA Inspection 1130716 - 2019-06-07
- FDA Inspection 1117032 - 2019-05-29
- FDA Inspection 1072267 - 2018-10-31
- FDA Inspection 1068733 - 2018-09-20
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