Cton LaboratoriesJuly 25, 2025

FDA 483 - Cton Laboratories - July 25, 2025

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Record Details

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.

Company: Cton Laboratories
Inspection Date: July 25, 2025
Product Type: Biologics
Office: Los Angeles District Office
People: Maurine Fadlalla (FDA_PERSONNEL)
Creighton T. Tuzon

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ID · e7d41862-fa3a-4dd4-837a-0c59b280826f