Gentherm Medical, LLC, Blue Ash, OH – FDA Inspections

Inspection records and compliance data for Gentherm Medical, LLC in Blue Ash, Ohio. 8 FDA inspections on record (1 OAI), 3 Form 483s, last inspected October 09, 2020.

Company Profile

This profile covers Gentherm Medical, LLC based in Blue Ash, Ohio, United States.

FDA Inspection History

FDA inspections: 8
OAI: 1
VAI: 3
NAI: 3
Unclassified: 1
Form 483s: 3
Warning letters: 0

First inspected July 15, 2009. Last inspected October 9, 2020.

Most cited issue areas

Design validation- Lack of or inadequate procedures2 inspections
Lack of or inadequate complaint procedures2 inspections
Lack of or inadequate procedures2 inspections

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
October 9, 2020	NAI	Medical Devices & Rad Health · Compliance: Devices	1133261
August 30, 2018	VAI	Medical Devices & Rad Health · Compliance: Devices	1063862
August 25, 2017	Not classified	Medical Devices & Rad Health	1041699
January 18, 2017	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1003116
March 1, 2013	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	820605
November 18, 2011	VAI	Medical Devices & Rad Health · Compliance: Devices	753901
December 14, 2009	OAI	Medical Devices & Rad Health · Compliance: Devices	634697
July 15, 2009	VAI	Medical Devices & Rad Health · Compliance: Devices	589572

FDA documents

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

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