FDA Inspection
Thomas A Tomsick MDThomas A Tomsick MD – FDA Inspection, Jul 16, 2010
Record Details
This FDA Inspection record concerns Thomas A Tomsick MD, with an inspection on July 16, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Thomas A Tomsick MD
- Inspection Date
- July 16, 2010
- Product Type
- Devices
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ID · 858b2682-e146-4c27-a635-7a75c4088b49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 672099
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.110(a)Informed consent obtained prior to study approval
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