FDA Inspection
Carl Owada, MDCarl Owada, MD – FDA Inspection, Aug 13, 2012
Record Details
This FDA Inspection record concerns Carl Owada, MD, with an inspection on August 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Carl Owada, MD
- Inspection Date
- August 13, 2012
- Product Type
- Devices
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ID · 009f4573-c275-41cd-bb48-4c2a9290043d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794936
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 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)(2)(iii)Investigator records of disposition of devices inadequate
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