FDA Inspection
Gentherm Medical, LLCGentherm Medical, LLC – FDA Inspection, Aug 30, 2018
Record Details
This FDA Inspection record concerns Gentherm Medical, LLC, with an inspection on August 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Christina L. Bigham (FDA Associated Person)
- Teresa K. Kastner
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ID · 3c36228e-1ebe-489d-b478-1576d8a1dec3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063862
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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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 25, 2017 | Not classified | Cincinnati District Office | |
| January 18, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 1041699 - 2017-08-25
- FDA Inspection 1003116 - 2017-01-18
- FDA Inspection 820605 - 2013-03-01
- FDA Inspection 753901 - 2011-11-18
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