FDA Inspection
Boston Scientific Cork, Ltd.Boston Scientific Cork, Ltd. – FDA Inspection, Apr 14, 2016
Record Details
This FDA Inspection record concerns Boston Scientific Cork, Ltd., with an inspection on April 14, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Boston Scientific Cork, Ltd.
- Inspection Date
- April 14, 2016
- Product Type
- Devices
View Company Profile
ID · c8318627-ed75-4855-a514-64f7ed1d6a2a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971389
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boston Scientific Cork, Ltd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2026 | Not classified | Office of Inspections and Investigations | New Drug Evaluation |
| June 12, 2019 | Not classified | Office of Inspections and Investigations | |
| October 12, 2017 | Not classified | Office of Inspections and Investigations | |
| October 2, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 10, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Boston Scientific Cork, Ltd.
- FDA Inspection 1325078 - 2026-06-30
- FDA Inspection 1116871 - 2019-06-12
- FDA Inspection 1043383 - 2017-10-12
- FDA Inspection 898966 - 2014-10-02
- FDA Inspection 831565 - 2013-05-10
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