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483
•Steven W. Boyce, M. D.•September 15, 2011

Steven W. Boyce, M. D. – FDA 483, Sep 15, 2011

Record Details

Steven W. Boyce, M.D., Clinical Investigator, was cited for significant deficiencies in conducting a clinical investigation. The inspection revealed failures related to IRB continuing review approval, improper informed consent documentation, and non-adherence to the investigational protocol. These issues indicate a lack of oversight and control over critical aspects of human subject protection and data integrity.

Company
Steven W. Boyce, M. D.
Inspection date
September 15, 2011
Product type
drugs
Office
Division of Human and Animal Food Operations - East II
Person
  • Krista Flores
View Company Profile

ID · 3612f2d2-05b7-458d-9464-71cd60542d14

Other documents for Steven W. Boyce, M. D.
  • EIR - 2011-09-15September 15, 2011

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