FDA Inspection
BioCARE CorporationBioCARE Corporation – FDA Inspection, Mar 22, 2012
Record Details
This FDA Inspection record concerns BioCARE Corporation, with an inspection on March 22, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BioCARE Corporation
- Inspection Date
- March 22, 2012
- Product Type
- Devices
View Company Profile
ID · fe507bb5-9714-440e-ba0c-be3f9218fbbe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 778985
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - documentation
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