FDA 483 - Lernapharm (Loris) Inc. - May 06, 2022

Lernapharm Inc. in Saint-Laurent was inspected by the FDA from April 28 to May 6, 2022, resulting in two observations. The inspection revealed issues with the evaluation of labeling reconciliation discrepancies and deficiencies in laboratory controls, including inadequate sterility testing conditions and incomplete software validation for critical analytical systems. These findings indicate significant concerns regarding the firm's quality control and data integrity practices.