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

Source: https://www.keypedia.com/records/warning_letter/montgomery-womens-medical-center-pc/f9c2b6b2-542d-4768-b7ac-82570a80722c

> FDA WARNING_LETTER for montgomery women's medical center pc  on January 21, 2020. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: montgomery women's medical center pc 
- Inspection Date: 2020-01-21
- Product Type: Biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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

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