FDA 483 - Galbraith Laboratories Inc - March 02, 2022

An FDA inspection of Galbraith Laboratories Inc, a control testing laboratory in Knoxville, TN, revealed significant deficiencies in their quality systems. The firm failed to perform routine inspections and audit trail reviews for electronic equipment, and their quality control unit lacked the authority to properly investigate errors and oversee the CAPA system. These issues indicate a need for improved adherence to written procedures and quality assurance practices.