FDA 483 - Central Coast Multispecialty Medical Group, Inc. - April 14, 2022

An FDA inspection of Central Coast Multispecialty Medical Group, Inc. in Monterey, CA, a human tissue establishment, revealed significant deficiencies in donor screening and testing for communicable diseases. The firm failed to adequately test oocyte donors for West Nile Virus and utilized an outdated donor medical history form that did not sufficiently screen for Zika Virus and Creutzfeldt-Jakob disease risk factors. Additionally, the firm lacked comprehensive written procedures for screening and determining the eligibility of HCT/P donors for relevant communicable diseases.