FDA 483 - Opada Alzohaili, M.D. - August 14, 2013

Opada Alzohaili, M.D. in Dearborn, MI, was cited for significant deficiencies in conducting a clinical investigation. The inspection revealed failures in adhering to the investigational plan, including delays in subject rescue/dose titration, improper investigational product administration and storage, and incomplete safety assessments. Additionally, the firm failed to obtain proper informed consent, maintain accurate case histories, and retain investigational records as required.