FDA 483 - GenCure Tissue Center - February 14, 2020

GenCure Tissue Center in San Antonio, TX, an HCT/P Recovery Facility, was cited for inadequate investigation and corrective actions regarding environmental monitoring deviations. The firm failed to determine the cause or implement preventative measures for repeated instances of unacceptable Colony Forming Units (CFUs) in cleanroom areas. This indicates a significant lapse in quality control and deviation management.