FDA 483 - CorneaGen - Boston - December 20, 2024

CorneaGen - Boston, a human tissue establishment, was cited for significant deficiencies related to donor eligibility and product distribution during an FDA inspection. The firm failed to properly determine ineligible donors with clinical evidence of sepsis and distributed corneas before completing donor eligibility determinations. These issues indicate a serious lapse in ensuring the safety and suitability of human tissue products.