FDA 483 - Sperm Bank, Inc - June 12, 2024

An FDA inspection of Sperm Bank, Inc. in San Diego, CA, revealed significant deficiencies in donor eligibility determination and communicable disease testing practices. The firm failed to collect donor specimens at appropriate times and did not adequately test repeat anonymous semen donors for West Nile Virus (WNV) during the required season. Additionally, the company's internal protocols and donor screening forms were found to be outdated and insufficient for ensuring compliance with WNV screening requirements.