FDA 483 - C.G. Laboratories, Inc. - July 24, 2025

An FDA inspection of C.G. Laboratories, Inc. in Granbury, TX, an HCT/Ps Testing Laboratory, revealed significant deficiencies in their quality system. The firm failed to implement adequate corrective and preventive actions, did not retain preventive maintenance records for the required duration, and lacked established procedures for critical equipment maintenance. These issues indicate a failure to meet core Current Good Tissue Practice (CGTP) requirements.