FDA 483 - Cosmax Nbt Usa, Inc. - May 04, 2021

Cosmax NBT USA received a Form 483 for significant deficiencies in its quality control and manufacturing processes for dietary supplements. Observations included failing to reject out-of-specification components and finished products, using unvalidated testing methods, and not establishing appropriate specifications. The firm also faced issues with record-keeping, adherence to master manufacturing records, and failure to register as an acidified food manufacturer.