Company
IrelandBoston Scientific Cork, Ltd., Cork, Ireland – FDA Inspections
Inspection records and compliance data for Boston Scientific Cork, Ltd. in Cork. 7 FDA inspections on record, 2 Form 483s, last inspected June 30, 2026.
Company Profile
This profile covers Boston Scientific Cork, Ltd. based in Cork, Ireland.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Unclassified
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected March 24, 2011. Last inspected June 30, 2026.
Most cited issue areas
- Control procedures to monitor and validate performance1 inspection
- Documentation1 inspection
- Lack of System for Event Evaluations1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 30, 2026 | Not classified | Human Drugs · New Drug Evaluation | 1325078 |
| June 12, 2019 | Not classified | Medical Devices & Rad Health | 1116871 |
| October 12, 2017 | Not classified | Medical Devices & Rad Health | 1043383 |
| April 14, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 971389 |
| October 2, 2014 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 898966 |
| May 10, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 831565 |
| March 24, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 718119 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Boston Scientific Cork, Ltd.
FEI Number
3002913962
Address
Model Farm Road, Cork, Ireland
Country
Ireland
ID: f0231c4f-e3fc-4028-ad4d-76d46f2eb601