FDA WARNING_LETTER - Cooper Institute for Advanced Reproductive Medicine - July 19, 2021

The FDA conducted an inspection of Cooper Institute for Advanced Reproductive Medicine from July 8-19, 2021, identifying significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to test for communicable disease agents (21 CFR 1271.85(a))**: Anonymous oocyte donors were not tested for West Nile Virus (WNV) during the specified period, and one donor was not tested for HIV-1/2, HBV, HCV, and Treponema pallidum at the time of recovery. 2. **Failure to test for genitourinary tract agents (21 CFR 1271.85(c))**: No record of testing for Chlamydia trachomatis and Neisseria gonorrhea for an anonymous oocyte donor. 3. **Failure to document donor eligibility (21 CFR 1271.50(a))**: Records for multiple anonymous oocyte donors lacked documentation of donor eligibility determination, including the responsible person's name, date, and "eligible" status. 4. **Failure to screen donors (21 CFR 1271.75(a))**: The donor questionnaire was missing screening questions for Zika Virus (ZIKV) risk factors, Creutzfeldt-Jakob