FDA 483 - Tennessee Reproductive Medicine - August 04, 2022

An FDA inspection of Tennessee Reproductive Medicine in Chattanooga, TN, revealed significant deficiencies in their donor eligibility determination processes for reproductive tissues. The firm lacked adequate procedures for screening donors against various health risks and travel histories, and released HCT/Ps without complete testing or proper warning labels. These findings indicate a failure to ensure compliance with donor eligibility requirements and appropriate product handling.