Boston Scientific Corp. (NYSE: BSX), Coventry, RI – FDA Inspections

Inspection records and compliance data for Boston Scientific Corp. in Coventry, Rhode Island. 10 FDA inspections on record (2 OAI), last inspected February 15, 2023. Publicly traded as NYSE: BSX.

Company Profile

This profile covers Boston Scientific Corp. based in Coventry, Rhode Island, United States.

FDA Inspection History

FDA inspections: 10
OAI: 2
VAI: 2
NAI: 3
Unclassified: 3
Form 483s: 0
Warning letters: 0

First inspected December 12, 2008. Last inspected February 15, 2023.

Most cited issue areas

Quarantine of finished devices2 inspections
DHR - not or inadequately maintained1 inspection
Documentation1 inspection

FDA inspections (10)

Date	Result	FDA center(s)	Insp. #
February 15, 2023	Not classified	Medical Devices & Rad Health	1198479
October 8, 2018	Not classified	Medical Devices & Rad Health	1122692
September 13, 2018	NAI	Medical Devices & Rad Health · Compliance: Devices	1066822
November 9, 2017	Not classified	Medical Devices & Rad Health	1051763
March 10, 2015	VAI	Medical Devices & Rad Health · Compliance: Devices	924170
March 18, 2013	NAI	Medical Devices & Rad Health · Compliance: Devices	825230
January 28, 2011	VAI	Medical Devices & Rad Health · Bioresearch Monitoring	709045
September 24, 2009	NAI	Medical Devices & Rad Health · Compliance: Devices	614007
February 12, 2009	OAI	Medical Devices & Rad Health · Compliance: Devices	564161
December 12, 2008	OAI	Medical Devices & Rad Health · Compliance: Devices	552978

FDA documents

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

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