FDA Inspection
UniDentalDirect, LLCUniDentalDirect, LLC – FDA Inspection, Mar 14, 2013
Record Details
This FDA Inspection record concerns UniDentalDirect, LLC, with an inspection on March 14, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- UniDentalDirect, LLC
- Inspection Date
- March 14, 2013
- Product Type
- Devices
View Company Profile
ID · e4c0cc24-18e8-40ce-8372-01212b863464
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823506
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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