FDA 483 - E2P4 Labs - September 17, 2024

An FDA inspection of E2P4 Labs, a reproductive firm in Plano, TX, revealed three observations related to deficiencies in their handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to properly document donor eligibility determinations in summaries of records and lacked adequate written procedures for record retention and for determining donor eligibility. These findings indicate significant issues with the firm's quality system and compliance with HCT/P regulations.