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

The FDA issued a Warning Letter to Laboratoires Druide Inc. following an inspection from February 10-14, 2025, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to conduct identity testing for components:** The firm did not adequately test incoming inactive ingredients, including glycerin, for identity and high-risk contaminants like diethylene glycol (DEG) and ethylene glycol (EG), relying on supplier COAs without validation. Their response was inadequate as it lacked commitment to identity testing and assessment of previously distributed products. 2. **Inadequate production and process controls:** * **Water system validation:** The firm failed to qualify their water system, lacking testing for total organic carbon (TOC), having inappropriate conductivity limits, and not monitoring for biofilm-forming microbes. Out-of-specification results were not investigated. The response was inadequate, lacking supporting documentation and a risk assessment for affected products. * **Process validation:** The firm lacked process validation data for OTC drug products, including bulk hold time studies, and could not demonstrate that hold times did not adversely affect drug quality. The response was inadequate, lacking a timeframe for validation and an interim plan for distributed drugs. 3. **Failure to establish and follow adequate cleaning and maintenance procedures:** The firm had not conducted cleaning validation studies or provided cleaning logs, failing to demonstrate adequate