FDA Inspection
Chimowitz, Marc MbchbChimowitz, Marc Mbchb – FDA Inspection, Dec 17, 2010
Record Details
This FDA Inspection record concerns Chimowitz, Marc Mbchb, with an inspection on December 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Chimowitz, Marc Mbchb
- Inspection Date
- December 17, 2010
- Product Type
- Devices
View Company Profile
ID · 3a22fbb6-fc3e-4910-b508-117a8f642467
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702488
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 812.43(c)No investigator agreement
- 21 CFR 812.150(b)(4)No 6-month sponsor reports of current investigators
- 21 CFR 812.150(b)(6)Sponsor notif. of rqst. to return/repair/dispose not timely
- 21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
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