FDA Inspection
Mt.Derm GmbhMt.Derm Gmbh – FDA Inspection, Jan 26, 2023
Record Details
This FDA Inspection record concerns Mt.Derm Gmbh, with an inspection on January 26, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 728dd3f8-8f79-4488-ba41-d5694f0df987
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196535
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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