FDA 483 - SURGENEX LLC - March 29, 2023

An FDA inspection of SURGENEX LLC in Scottsdale, AZ, from March 22-29, 2023, revealed a significant issue with quality control. The firm failed to adequately control in-process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and did not ensure sterilization validation requirements were met before product release. This included a failure to process dose audit samples and a delay in opening a deviation report.