FDA WARNING_LETTER - montgomery women's medical center pc - January 21, 2020

On May 14, 2020, the FDA issued a Warning Letter to Montgomery Fertility Center following an inspection from January 8-21, 2020. The inspection revealed 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 1271.55(a))**: Anonymous oocyte donors were not tested for HIV-1, HCV, and HBV by NAT, nor for West Nile Virus (WNV) during the specified period (June 1st - October 31st). 2. **Failure to screen donors for risk factors (21 CFR 1271.75(a)(1))**: The donor medical history questionnaire lacked screening for all relevant communicable disease risks, specifically Zika Virus (ZIKV) exposure within the past 6 months (only asked for 120 days) and did not include all CDC-identified ZIKV risk areas. Some donor questionnaires also had missing answers for ZIKV risk screening.

The FDA acknowledged the firm's January 27, 2020, response to the FDA-483. While procedures were updated for HIV-1/HCV/HBV NAT and WNV testing, donor eligibility determinations for