FDA 483 - Les Produits Chimiques B.G.R., Inc. - February 28, 2025

An FDA inspection of Les Produits Chimiques B.G.R., Inc., an API manufacturer in Pointe-Claire, revealed significant deficiencies in their quality systems. Observations included a failure to qualify manufacturing equipment, incomplete method verification studies for analytical testing, and an inadequate investigation into an out-of-specification raw material result. These issues indicate a lack of robust controls over API production and quality assurance.