Central Coast Multispecialty Medical Group, Inc. Warning Letter Details

Summary

Central Coast Multispecialty Medical Group, Inc., a biologics firm specializing in human cells, tissues, and cellular products (HCT/Ps), failed to adequately screen reproductive cell donors for communicable disease risk factors as required under 21 CFR 1271.75(a)(1). The firm's Donor Eligibility Questionnaire and Donor Medical History Interview Form lacked required screening questions, timeframes, and deferral periods to assess critical communicable disease risks, including screening for individuals with hepatitis B infection and relevant sexual history indicators. The violations were documented during an FDA inspection conducted May 13-16, 2025, at the firm's Monterey, California facility.