FDA 483 - CGG Medical Inc - February 11, 2019

Veritas Surgical Solutions, a human tissue distributor in Tallahassee, FL, was cited for significant deficiencies in its quality system. The inspection revealed a widespread lack of established, documented, and followed procedures for critical operations, including HCT/P manufacturing steps, record-keeping, facility sanitation, and complaint handling. These issues indicate a fundamental breakdown in maintaining current good tissue practices.