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Talk to a SpecialistTalk to a SpecialistLes Importations Herbasanté Inc., a Canadian contract manufacturer of homeopathic drug products, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. During an August 2023 inspection, the FDA identified critical violations including the company's failure to adequately sample and test drug components and containers before use, and its failure to validate supplier testing reliability at appropriate intervals. The company particularly failed to perform adequate identity testing of each drug component lot, including higher-risk components like glycerin that are susceptible to contamination with diethylene glycol and ethylene glycol, and instead relied solely on suppliers' certificates of analysis without establishing their testing reliability.