FDA Inspection
Boston Scientific CorporationBoston Scientific Corporation – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns Boston Scientific Corporation, with an inspection on September 22, 2017, issued by the Minneapolis District Office, covering medical devices & rad health.
- Inspection Date
- September 22, 2017
- Product Type
- Medical Devices & Rad Health
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ID · 3d945730-00a6-4bcd-b579-db8726582b8b
Inspection Facts
- Inspection number
- 1026092
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 58.120(b)Protocol: approval of changes
- 21 CFR 58.130(a)Conduct: in accordance with protocol
- 21 CFR 58.185(a)(10)Final report: names of those involved
- 21 CFR 58.195(b)Archives: retention for appropriate time
- 21 CFR 58.29(a)Personnel: education, training, experience
- 21 CFR 58.31(b)Management: replacing the study director
- 21 CFR 58.31(d)Management: testing of test and control articles
- 21 CFR 58.31(f)Management: personnel understand their functions
- 21 CFR 58.33(c)Study director: unforeseen circumstances
- 21 CFR 58.33(f)Study director: transfer of data to archives
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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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