FDA 483 - Laboratoires Druide inc. - February 14, 2025

During an FDA inspection conducted from February 10-14, 2025, Laboratoires Druide inc., an OTC drug manufacturer in Pointe-Claire, H9R 1A8, received a Form 483 outlining significant deficiencies in their manufacturing and quality control operations. The inspection identified eight observations indicating non-compliance with current Good Manufacturing Practices (CGMP) for drug products.

Key issues included a lack of assurance in the water system's ability to produce compliant water, evidenced by deficient performance qualification, uninvestigated Out-of-Specification results, and inadequate testing. The firm also failed to verify the identity of incoming raw materials and excipients, relying solely on supplier certificates of analysis without independent testing. Further observations highlighted inadequate equipment cleaning and maintenance procedures, including the use of shared equipment without validated cleaning to prevent cross-contamination, and a lack of proper cleaning logs. Laboratoires Druide inc. also failed to perform process validation for their numerous drug products or establish in-process material hold times. Deviations from written sampling plans for micro and other testing were noted, with insufficient data and justifications. Equipment qualification records were lacking for critical manufacturing and stability storage units. Additionally, employee training was found to be deficient, particularly concerning revised procedures and CGMP requirements, and the firm lacked written procedures and had not conducted annual product reviews to assess drug product quality.

To address these findings, Laboratoires Druide inc. is required to submit a comprehensive response detailing corrective and preventive actions for each observation to ensure future compliance with regulatory standards for drug manufacturing.