FDA 483 - Les Produits Chimiques B.G.R., Inc. - January 07, 2019

An FDA inspection of Les Produits Chimiques B.G.R., Inc. in Pointe-Claire, Quebec, an API manufacturer, revealed significant deficiencies in quality assurance, production, and laboratory controls for (b)(4) USP Powder. The firm was cited for issues including inadequate raw material approval, deficient cleaning validation, lack of sampling plans, and poor documentation in batch records and analytical testing. Many of these observations were repeats from a previous inspection, indicating persistent non-compliance.