FDA 483 - Biograft Transplant Services Inc - February 26, 2026

Biograft Transplant Services Inc., a tissue recovery establishment located in Houston, Texas, underwent an FDA inspection from February 24, 2026, to February 26, 2026. The inspection identified critical gaps in the facility’s environmental control protocols within its dedicated recovery suite. Specifically, the firm failed to implement a program for monitoring microorganisms, including air quality, surface, and personnel testing. Since 2022, tissue products from a significant number of donors were processed without any assessment of the recovery environment’s microbiological quality. Additionally, the company lacked written procedures to define monitoring locations, frequencies, or corrective actions for potential contamination events. These findings were documented under the regulatory framework of the Food, Drug, and Cosmetic Act, which addresses insanitary conditions that may compromise product safety. While the report does not represent a final agency determination, the company is required to respond by either contesting the observations or detailing a plan for corrective actions. Establishing rigorous environmental monitoring and formalizing quality control procedures are necessary steps to ensure compliance and tissue safety.