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Dibar Nutricional S. de R.L. de C.V., a Mexican manufacturer of over-the-counter drug products, failed to comply with current good manufacturing practices (CGMP) for finished pharmaceuticals, resulting in adulterated drug products. The company did not conduct adequate identity testing of incoming component ingredients before release and distribution to the United States, relying instead on random sampling and sensory evaluation rather than required chemical and microbiological testing for each lot. This violation of 21 CFR 211.84(d)(1) meant the firm could not verify the identity of each component used in its drug products.