FDA 483 - Gimopharm Sarl - July 30, 2019

This FDA Form 483 report details significant deficiencies at Ginopharm Sarl, a contract testing laboratory in Longjumeau, France, following an inspection from July 29-30, 2019. The observations highlight inadequate laboratory controls, poor record-keeping, failures within the quality control unit, and insufficient employee training, with several issues being repeat observations from a 2014 inspection. These findings indicate a lack of adherence to current good manufacturing practice regulations.