Sperm Bank, Inc. dba Fertility Center of California

Warning LetterClosed

Martin D. Bastuba, M.D. Owner/Medical Director Sperm Bank, Inc. dba Fertility Center of California 6699 Alvarado Road, Suite 2208 San Diego , CA 92120 United States Director@fertilityCTR.comFEI 3005210448Issued Feb 14, 2025Center 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 3005210448.

Letter Details

Firm: Sperm Bank, Inc. dba Fertility Center of California
Location: Martin D. Bastuba, M.D. Owner/Medical Director Sperm Bank, Inc. dba Fertility Center of California 6699 Alvarado Road, Suite 2208 San Diego , CA 92120 United States Director@fertilityCTR.com
FEI Number: 3005210448
Country: United States
Issue Date: February 14, 2025
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Biologics
Status: Closed
Closeout Letter: February 19, 2026

Summary

Sperm Bank, Inc. dba Fertility Center of California, a biologics firm handling human cells and tissues for reproductive purposes, failed to comply with FDA regulations for human cell, tissue, and cellular products (HCT/Ps) under 21 CFR Part 1271. During a June 2024 inspection, the FDA documented significant deviations including failure to perform required communicable disease testing on anonymous and directed reproductive donors, specifically noting that repeat semen donors were not tested for West Nile Virus using FDA-licensed nucleic acid tests during the required June-October testing periods. The violations represented critical gaps in donor screening and eligibility determination processes that could compromise product safety and recipient health.

Sperm Bank, Inc. dba Fertility Center of California FDA Warning Letter, February 14, 2025