FDA Inspection
Boston Scientific LimitedBoston Scientific Limited – FDA Inspection, Aug 31, 2017
Record Details
This FDA Inspection record concerns Boston Scientific Limited, with an inspection on August 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d8532722-d696-43c1-8121-942588376759
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025569
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boston Scientific Limited
8| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2025 | Not classified | Office of Inspections and Investigations | |
| June 29, 2018 | Not classified | Office of Inspections and Investigations | |
| October 20, 2017 | Not classified | Office of Inspections and Investigations | |
| September 1, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 10, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Boston Scientific Limited
- FDA Inspection 1295876 - 2025-11-13
- FDA Inspection 1078086 - 2018-06-29
- FDA Inspection 1045379 - 2017-10-20
- FDA Inspection 986155 - 2016-09-01
- FDA Inspection 878978 - 2014-04-10
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