FDA 483 - Central Coast Multispecialty Medical Group, Inc. - May 16, 2025

Central Coast Multispecialty Medical Group, Inc. in Monterey, CA, was cited for significant deficiencies in its human reproductive tissue donor screening and eligibility determination processes. The inspection revealed failures to deem ineligible donors with communicable disease risk factors, inadequate screening of sperm and egg donors, and a lack of comprehensive written procedures for donor eligibility. These issues, including repeat observations, indicate a serious risk to public health due to potential transmission of communicable diseases through human reproductive tissue.