FDA 483 - Cton Laboratories - July 25, 2025

CTON Corporation, a testing laboratory in Torrance, CA, was cited for significant deficiencies during an FDA inspection. The firm failed to establish and maintain core Current Good Tissue Practice (CGTP) procedures for the manufacture and testing of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), particularly concerning communicable disease prevention and contamination control. Additionally, the quality program was not adequately established or maintained, and records lacked necessary detail for traceability.