FDA 483 - Cton Laboratories - July 25, 2025

CTON Corporation in Torrance, CA, a testing laboratory for HCT/Ps, received a Form 483 with three observations. The inspection revealed significant deficiencies in establishing and maintaining core Current Good Tissue Practice (CGTP) procedures, a lack of an adequate quality program, and insufficient detail in records. These issues indicate a risk of contamination, cross-contamination, and the spread of communicable diseases.