FDA 483 - Quali Controle - December 13, 2024

Quali Controle, a control testing laboratory in Meru, France, was cited for significant deficiencies during an FDA inspection. The inspection revealed that test methods used for analyzing samples, including those for the U.S. market, were not properly validated or verified. Additionally, the firm failed to thoroughly review out-of-specification discrepancies, with investigations either remaining open without justification or being closed without adequate corrective and preventive actions.