Boston Scientific Limited (NYSE: BSX), Galway, Ireland – FDA Inspections

Inspection records and compliance data for Boston Scientific Limited in Galway. 9 FDA inspections on record, 2 Form 483s, last inspected November 13, 2025. Publicly traded as NYSE: BSX.

Company Profile

This profile covers Boston Scientific Limited based in Galway, Ireland.

FDA Inspection History

FDA inspections: 9
OAI: 0
VAI: 1
NAI: 5
Unclassified: 3
Form 483s: 2
Warning letters: 0

First inspected December 10, 2009. Last inspected November 13, 2025.

Most cited issue areas

Environmental control Lack of or inadequate procedures1 inspection
Lack of or inadequate complaint procedures1 inspection

FDA inspections (9)

Date	Result	FDA center(s)	Insp. #
November 13, 2025	Not classified	Human Drugs, Medical Devices & Rad Health	1295876
June 29, 2018	Not classified	Medical Devices & Rad Health	1078086
October 20, 2017	Not classified	Medical Devices & Rad Health	1045379
August 31, 2017	VAI	Medical Devices & Rad Health · Bioresearch Monitoring	1025569
September 1, 2016	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	986155
April 10, 2014	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	878978
March 21, 2013	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	827456
December 16, 2010	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	702566
December 10, 2009	NAI	Medical Devices & Rad Health · Compliance: Devices	637220

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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