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 and inadequate screening of sperm and egg donors. Additionally, the firm lacked comprehensive written procedures for donor eligibility requirements, including screening for specific diseases and physical examinations.