FDA Inspection
Ventracor, IncVentracor, Inc – FDA Inspection, Apr 30, 2009
Record Details
This FDA Inspection record concerns Ventracor, Inc, with an inspection on April 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ventracor, Inc
- Inspection Date
- April 30, 2009
- Product Type
- Devices
View Company Profile
ID · 8d0a4677-f7f5-46cb-bd2a-0be41f700410
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 582242
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.43(b)Sponsor shipped devices to unqualified person(s)
- 21 CFR 812.140(b)(2)Sponsor device disposition records inadequate
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