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

An FDA inspection was conducted at Opada Alzohaili, M.D., Dearborn, MI, from July 18 to August 14, 2013. This initial surveillance and clinical investigator data validation inspection, guided by the Bioresearch Monitoring Compliance Program Guidance Manual (7348.811) and referencing 21 CFR 312.60, focused on eight Glaxo SmithKline (GSK) sponsored "Harmony Program" drug studies (BLA #125431). The inspection identified significant objectionable conditions, resulting in the issuance of an FDA-483. Key violations included widespread protocol noncompliance, such as delays in rescue or dose titration for hyperglycemic subjects, incorrect administration of investigational product (albiglutide), and failures to conduct required efficacy/safety assessments or complete ECGs and IVRS calls as mandated. The site also failed to obtain proper informed consent for genetic sample collection and delayed re-consenting after protocol amendments. Furthermore, discrepancies were found between source documentation and case report forms regarding subject eligibility and visit completion. Finally, the site failed to maintain an insulin accountability log and improperly stored investigational product. The principal investigator committed to providing a written response within 15 days addressing these observations.