FDA Inspection
Kasirajan, Karthikeshwar, MdKasirajan, Karthikeshwar, Md – FDA Inspection, Jan 25, 2011
Record Details
This FDA Inspection record concerns Kasirajan, Karthikeshwar, Md, with an inspection on January 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kasirajan, Karthikeshwar, Md
- Inspection Date
- January 25, 2011
- Product Type
- Devices
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ID · 12c52eea-ba79-417f-aa1b-71ec93017154
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 707277
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.110(a)Subject participation prior to study approval
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