FDA Inspection
Quick-Med Technologies, IncQuick-Med Technologies, Inc – FDA Inspection, May 3, 2013
Record Details
This FDA Inspection record concerns Quick-Med Technologies, Inc, with an inspection on May 3, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Quick-Med Technologies, Inc
- Inspection Date
- May 3, 2013
- Product Type
- Devices
View Company Profile
ID · aa34b223-b6ea-4fe7-8cf3-1ab1b9444fe1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 830940
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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