FDA 483 - INFINITY-EKG LIFE SCIENCES MO LLC - October 27, 2021

EKG Life Science Solutions, LLC, a contract testing laboratory in Saint Louis, MO, was cited for significant deficiencies in its computer system controls. The inspection revealed a lack of appropriate controls to prevent unauthorized changes or deletion of electronic raw data, absence of electronic audit trails for chromatographic data, and no standard operating procedures for administering automated laboratory systems. These issues compromise data integrity and raise concerns about the reliability of laboratory records.