FDA 483 - Akyut Bayrak, MD. A Professional Corporation - July 21, 2022

Akyut Bayrak, MD. A Professional Corporation, a human reproductive tissue establishment in Pasadena, CA, was inspected by the FDA. The inspection revealed significant deficiencies in donor screening and testing for communicable disease agents, including a lack of testing for West Nile Virus and inadequate screening for sepsis and high-risk behaviors. Additionally, the firm failed to establish proper procedures for physical examinations and improperly included donor names in HCT/P records.