FDA 483 - Holodiag - March 23, 2022

Holodiag, a contract testing laboratory in Val de Reuil, France, was cited for three observations during an FDA inspection. The findings indicate significant deficiencies in data integrity, specifically regarding computer system controls and audit trails, as well as inadequate written procedures for complaint handling and employee cGMP training within the quality control unit. These issues highlight a lack of robust quality system controls.