FDA Inspection
Raimund Wenzler GmbhRaimund Wenzler Gmbh – FDA Inspection, Oct 24, 2013
Record Details
This FDA Inspection record concerns Raimund Wenzler Gmbh, with an inspection on October 24, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Raimund Wenzler Gmbh
- Inspection Date
- October 24, 2013
- Product Type
- Devices
View Company Profile
ID · b2dcd0fa-3d03-45f3-a65a-a58a3f284e61
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 855678
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
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