FDA Inspection
Bio Data CorpBio Data Corp – FDA Inspection, Jan 9, 2012
Record Details
This FDA Inspection record concerns Bio Data Corp, with an inspection on January 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bio Data Corp
- Inspection Date
- January 9, 2012
- Product Type
- Devices
View Company Profile
ID · b7dc7561-1f81-4ddb-a286-0c535b07e0aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 762719
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(f)Design verification - documentation
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.