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

Laboratoires Druide inc., an OTC drug manufacturer in Pointe-Claire, received an FDA Form 483 citing significant deficiencies across its quality system. Observations included inadequate equipment design and maintenance, failure to verify raw material identity, lack of process validation, and insufficient employee training. These issues indicate a systemic failure to adhere to cGMP requirements, potentially impacting the quality and safety of their drug products.