FDA Inspection
AMTRION GMBH (Formerly Haseke & Kroemker)AMTRION GMBH (Formerly Haseke & Kroemker) – FDA Inspection, Apr 6, 2018
Record Details
This FDA Inspection record concerns AMTRION GMBH (Formerly Haseke & Kroemker), with an inspection on April 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2b347ebc-dd1b-4b97-85e2-2001110c6fda
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047120
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of AMTRION GMBH (Formerly Haseke & Kroemker)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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