FDA 483 - Williams OB/GYN & Associates - May 24, 2021

An FDA inspection of Williams OB/GYN & Associates, a reproductive establishment in San Dimas, CA, revealed significant deficiencies in their human cells, tissues, and cellular and tissue-based products (HCT/P) program. The firm failed to properly document donor eligibility, adequately screen donors for communicable disease risks like Zika, West Nile Virus, and Syphilis, and perform all required communicable disease testing. Additionally, the firm's standard operating procedures for donor eligibility were found to be inadequate for oocyte donors.