FDA 483 - PMC Isochem - February 17, 2017

Isochem, an API manufacturer in Gennevilliers, France, received a Form 483 with seven observations during an FDA inspection from February 13-17, 2017. Significant issues included widespread data integrity failures, inadequate water system management, poor facility and equipment maintenance, and a deficient quality unit that failed to properly investigate complaints and out-of-specification results. This inspection highlighted critical deficiencies in the firm's quality systems and manufacturing controls.