FDA Inspection
Morcher GmbhMorcher Gmbh – FDA Inspection, Feb 2, 2023
Record Details
This FDA Inspection record concerns Morcher Gmbh, with an inspection on February 2, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c233cc5e-2787-49ab-bf18-0ed817c88fe9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196534
- 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 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
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