FDA Inspection
Edward Y. Woo, MDEdward Y. Woo, MD – FDA Inspection, Apr 23, 2012
Record Details
This FDA Inspection record concerns Edward Y. Woo, MD, with an inspection on April 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Edward Y. Woo, MD
- Inspection Date
- April 23, 2012
- Product Type
- Devices
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ID · 547895b5-9ce6-453c-a1da-c051dcab3270
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777724
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.140(a)(3)(ii)Investigator adverse effect records inadequate
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
- 21 CFR 812.140(a)(4)Investigator record of protocol deviations inadequate
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