FDA WARNING_LETTER - Strong Fertility Center - August 16, 2019

The FDA conducted an inspection of Strong Fertility Center in Rochester, NY, from August 12-16, 2019, identifying significant deviations from regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) under 21 CFR Part 1271. Key violations include the firm's failure to test anonymous or directed donors for relevant communicable disease agents, such as West Nile Virus (WNV) NAT during specific periods, as required by 21 CFR 1271.85(a). The firm also failed to determine HCT/P donor eligibility prior to implantation or transfer, as mandated by 21 CFR 1271.45(c), with multiple instances of post-transfer eligibility determinations. Additionally, Strong Fertility Center failed to adequately screen donors by reviewing medical records for communicable disease risk factors, per 21 CFR 1271.75(a)(1), citing incomplete donor interview forms. The FDA recommended a comprehensive review of all procedures to ensure compliance with 21 CFR 1271 Subpart C, including testing, screening, and donor eligibility documentation. HCT/Ps from donors with incomplete eligibility determinations must be quarantined under 21 CFR 1271.60(a). For oocytes and semen, an exemption request (21 CFR 1271.155) is required before release from quarantine, while embryos may be released if labeled correctly (21 CFR 1271.90(b) and (c)). The firm must take prompt corrective action and submit a written response within fifteen working days, detailing corrective steps and prevention plans.