FDA WARNING_LETTER - University Fertility Laboratory, Inc. - February 04, 2019

The FDA inspected University Fertility Laboratory, Inc. from December 7-13, 2018, and February 4, 2019, identifying significant deviations from HCT/P regulations (21 CFR Part 1271).

Violations include: 1. Failure to test donor specimens for relevant communicable disease agents, specifically West Nile Virus (WNV) for oocyte donors recovered between June 1st and October 31st, as per FDA guidance. 2. Failure to screen reproductive cell donors by reviewing medical records for risk factors and clinical evidence of communicable diseases. 3. Failure to document the name of the responsible person and the date of donor eligibility determination in records on twelve occasions. 4. Failure to determine donor eligibility based on complete screening and testing results, with examples of oocyte donors deemed eligible before all required communicable disease testing results were received. 5. Failure to establish and maintain procedures for donor testing, screening, and eligibility determination, including outdated SOPs and medical records.

The FDA found the firm's February 12, 2019, response inadequate. While a new questionnaire includes Zika Virus (ZIKV) screening, it's incomplete, and there's no FDA-licensed ZIKV donor screening test. Oocytes from donors with incomplete screening/testing must remain quarantined. Removal from quarantine requires an FDA exemption request with justification and risk mitigation. The letter also reminded