FDA 483 - SGS North America Inc. - January 10, 2023

An FDA inspection of SGS North America Inc., a control testing laboratory in Lincolnshire, IL, revealed a significant failure in thoroughly reviewing unexplained discrepancies and ensuring equipment meets specifications. Specifically, the firm did not properly assess the impact of an out-of-tolerance micropipette and lacked documentation for returning it to service after it was tagged out. This indicates deficiencies in their investigation and equipment management procedures.