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

The FDA issued a Warning Letter to Central Coast Multispecialty Medical Group, Inc. on January 29, 2026, following an inspection from May 13-16, 2025. The inspection revealed significant violations of regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps), specifically 21 CFR Part 1271. The main issues identified included the company's failure to adequately screen reproductive cell and tissue donors for communicable disease risks. Donor eligibility questionnaires were found incomplete, omitting crucial questions regarding sexual history, drug use, tattoo/piercing practices, smallpox vaccination, West Nile Virus, and specific Creutzfeldt-Jakob Disease risk factors related to time spent in Europe. The firm also failed to correctly deem a donor ineligible despite a disclosed risk factor, and prematurely determined donor eligibility before receiving all required communicable disease test results. Furthermore, the company lacked established written procedures for donor screening and eligibility, relying instead on verbal guidance. The FDA requires prompt corrective action to address all violations and prevent their recurrence. Central Coast Multispecialty Medical Group, Inc. must submit a written response within fifteen working days detailing specific corrective steps, prevention plans, and supporting documentation. Additionally, all stored oocytes, semen, or embryos from donors with incomplete eligibility determinations must be quarantined, and an FDA exemption is required before their release or use.