FDA 483 - Cosmax Nbt Usa, Inc. - November 22, 2019

Cosmax NBT received a Form 483 citing significant deficiencies in its quality control and manufacturing processes for dietary supplements. The firm repeatedly released out-of-specification products and components without proper investigation or rejection, failed to establish adequate specifications for finished products and raw materials, and demonstrated poor control over testing methods, supplier qualification, and record-keeping. These issues indicate a systemic breakdown in ensuring product quality, purity, and strength.