FDA WARNING_LETTER - The New Hope Center for Reproductive Medicine - January 23, 2023

The FDA inspected The New Hope Center for Reproductive Medicine from December 8, 2022, to January 23, 2023, and found significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to screen donors:** The firm failed to review relevant medical records for risk factors and clinical evidence of relevant communicable disease agents and diseases (RCDADs). Donor questionnaires were missing or incomplete, lacking required screening questions for RCDADs. Physical examinations were not conducted within the required timeframe (e.g., one donor's exam was over a year prior to donation). 2. **Failure to collect donor specimens for testing at the appropriate time:** A specimen for communicable disease testing was collected outside the permissible timeframe for an anonymous oocyte donor. 3. **Failure to establish and maintain adequate procedures:** The firm's procedures for donor testing, screening, and eligibility determination were deficient, lacking comprehensive steps and criteria required by 21 CFR 1271.47(a) and Subpart C.

The FDA reviewed the firm's February 3, 2023, response but deemed it inadequate. The revised Donor Medical History Interview Form still lacked critical screening questions for RCDADs (e.g., past viral hepatitis, West Nile