FDA Inspection
BIOVISIONBIOVISION – FDA Inspection, Apr 30, 2015
Record Details
This FDA Inspection record concerns BIOVISION, with an inspection on April 30, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BIOVISION
- Inspection Date
- April 30, 2015
- Product Type
- Devices
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ID · 956821c5-29b1-47bc-85e2-ed9a383a41b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 925870
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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