FDA 483 - Genecell International, LLC - September 19, 2018

This FDA Form 483 was issued to Genecell International, LLC in Doral, FL, a human tissue establishment. The inspection revealed significant deficiencies in process validation, environmental controls, equipment maintenance, corrective actions, and the establishment of critical procedures for donor screening, eligibility determination, and HCT/P receipt and distribution. These issues indicate a lack of adequate controls to prevent contamination and ensure product quality and safety.