FDA Inspection
Vero Biotech LLCVero Biotech LLC – FDA Inspection, Aug 29, 2014
Record Details
This FDA Inspection record concerns Vero Biotech LLC, with an inspection on August 29, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vero Biotech LLC
- Inspection Date
- August 29, 2014
- Product Type
- Devices
View Company Profile
ID · 0c7aefc7-28c7-4849-915b-317a8ca35427
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 893188
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.30(g)Design validation - software validation not performed
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