FDA 483 - Fangyinmeng MD Inc. - February 18, 2025

An FDA inspection of Fangyimmeng MD Inc., a human reproductive tissue establishment in Irvine, CA, identified significant deficiencies in their procedures and documentation related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) donor eligibility. The firm failed to establish and maintain adequate procedures for screening and determining donor eligibility, specifically regarding physical examinations. Additionally, the firm did not maintain proper documentation of donor-eligibility determinations and their corresponding dates.