FDA WARNING_LETTER - Seattle Sperm Bank, LLC - May 24, 2011

The FDA conducted an inspection of the firm in Seattle, Washington, from May 9 to May 24, 2011, identifying significant deviations from regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) under 21 CFR Part 1271. A Form FDA 483 was issued detailing these deficiencies. Key violations included the failure to determine as ineligible donors with risk factors for relevant communicable disease agents or diseases (RCDADs), such as variant Creutzfeldt-Jakob Disease (vCJD) for donors from Denmark, and a donor with a history of testing positive for Hepatitis B surface antigen. The firm also failed to determine as ineligible a donor whose specimen tested reactive for syphilis. Furthermore, deficiencies were noted in donor screening procedures, specifically the failure to review medical records for risk factors and to perform complete donor screenings, including physical examinations, within the required six-month period for repeat donors. The firm's procedures were found inadequate, allowing physical examinations at intervals up to seven months, violating 21 CFR 1271.75(e). The FDA acknowledged the firm's response but expressed continued concern regarding their interpretation of donor eligibility for TSEs like CJD, particularly for Danish donors, and deemed the firm's use of recipient waivers for ineligible donors non-compliant. The firm is required to take prompt corrective action and respond within 15 working days, outlining steps taken or a timeline for completion, to prevent further regulatory action.