FDA Inspection
Kleinmontagen Wiechmann GmbHKleinmontagen Wiechmann GmbH – FDA Inspection, Jan 30, 2013
Record Details
This FDA Inspection record concerns Kleinmontagen Wiechmann GmbH, with an inspection on January 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kleinmontagen Wiechmann GmbH
- Inspection Date
- January 30, 2013
- Product Type
- Devices
View Company Profile
ID · ae16c4dc-fc3c-4145-9d0e-88764ed9630e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820209
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.184DHR content
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