FDA 483 - Capcium Inc. - April 08, 2022

Capcium Inc., an OTC Drug Manufacturer in Pointe-Claire, was inspected by the FDA. The inspection revealed a significant issue related to the firm's failure to thoroughly investigate unexplained discrepancies, specifically an out-of-specification (OOS) result for a stability timepoint. This indicates a potential lack of robust quality control and adherence to established investigation procedures.