FDA 483 - Aptar France SAS - December 02, 2015

An FDA inspection of Aptar Pharma France, SAS, a testing laboratory in Le Vaudreuil, France, revealed significant deficiencies in laboratory controls. The firm was cited for inadequate verification of laboratory equipment, specifically balances, and for failing to properly investigate and trend laboratory incidents. These issues indicate a lack of robust quality control practices within the facility.