Central Coast Multispecialty Medical Group, Inc.

Warning LetterOpen

Edward J. Ramirez, MD, FACOG Executive Medical Director Central Coast Multispecialty Medical Group, Inc. 9833 Blue Larkspur Ln Monterey , CA 93940 United States ejrmd@montereybayivf.comFEI 3003969216Issued Jan 29, 2026Center for Biologics Evaluation and Research (CBER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003969216.

Violations5

Issue DateJan 29, 2026

Product TypeBiologics

StatusOpen

Letter Details

Firm: Central Coast Multispecialty Medical Group, Inc.
Location: Edward J. Ramirez, MD, FACOG Executive Medical Director Central Coast Multispecialty Medical Group, Inc. 9833 Blue Larkspur Ln Monterey , CA 93940 United States ejrmd@montereybayivf.com
FEI Number: 3003969216
Country: United States
Issue Date: January 29, 2026
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Biologics
Status: Open

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.

Central Coast Multispecialty Medical Group, Inc. FDA Warning Letter, January 29, 2026