FDA Inspection
Gentherm Medical, LLCGentherm Medical, LLC – FDA Inspection, Jan 18, 2017
Record Details
This FDA Inspection record concerns Gentherm Medical, LLC, with an inspection on January 18, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Christina L. Bigham (FDA Associated Person)
- Teresa K. Kastner
View Company Profile
ID · 961e54c5-b2db-4dd8-96f2-3c6d38a66383
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1003116
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Gentherm Medical, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 9, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 30, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2017 | Not classified | Cincinnati District Office | |
| March 1, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 18, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gentherm Medical, LLC
- FDA Inspection 1133261 - 2020-10-09
- FDA Inspection 1063862 - 2018-08-30
- FDA Inspection 1041699 - 2017-08-25
- FDA Inspection 820605 - 2013-03-01
- FDA Inspection 753901 - 2011-11-18
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