FDA 483 - Biograft Transplant Services Inc - August 27, 2021

An FDA inspection of Biograft Transplant Services Inc in Houston, TX, a human tissue establishment, revealed significant deficiencies in environmental monitoring and control within their recovery suite. The firm failed to monitor for microorganisms, control humidity, and maintain documentation for temperature control, raising concerns about potential contamination of human cells, tissues, and cellular and tissue-based products (HCT/Ps). These issues suggest a lack of adequate controls to prevent contamination and ensure product safety.