FDA 483 - Vivex Biologics, Inc. - December 18, 2015

UMTB Biomedical, Inc. in Miami, FL, a human tissue establishment, was cited for failing to validate its processing activities, including cleaning, cutting, freezing, drying, and sterilizing of human tissue products. This is a repeat observation from a previous inspection, indicating a persistent issue with ensuring effective processes to prevent infectious disease contamination and cross-contamination.