FDA 483 - Pelex Medical of Texas - July 28, 2023

An FDA inspection of Pelex Medical of Texas, a reproductive tissue establishment in Lubbock, TX, revealed significant deficiencies in donor eligibility and communicable disease testing procedures. The firm failed to test an oocyte donor for West Nile Virus and lacked approved procedures and comprehensive screening for relevant communicable disease risks, including Zika Virus. These issues indicate a failure to ensure the safety and eligibility of human cells, tissues, and cellular and tissue-based products (HCT/Ps).