FDA 483 - Les Produits Chimiques B.G.R., Inc. - September 25, 2017

The FDA inspection of Les Produits Chimiques B.G.R., Inc. in Pointe-Claire, Quebec, Canada, revealed significant deficiencies in quality control and manufacturing processes for Active Pharmaceutical Ingredients. Observations included unperformed QC tests reported as passed, inadequate documentation of analytical data and batch records, and a lack of environmental monitoring for retain samples. The firm also failed to ensure proper material sampling, pest control, equipment cleaning validation, and personnel training, indicating a broad lack of adherence to cGMP requirements.