FDA Inspection
DETAX GmbH & Co. KGDETAX GmbH & Co. KG – FDA Inspection, Apr 6, 2018
Record Details
This FDA Inspection record concerns DETAX GmbH & Co. KG, with an inspection on April 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ed8b25bb-7fb7-4b21-999d-1eef2a8f5d0f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047145
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.184DHR content
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