FDA 483 - Berkeley Nutritional Mfg Corp. - March 04, 2016

During an inspection, Berkeley Nutritional Mfg Corp., a dietary supplement manufacturer in Livermore, CA, was cited for multiple significant quality control deficiencies. The firm failed to establish and verify specifications for components and finished products, did not adequately qualify suppliers, and lacked proper sampling plans for in-process materials. These observations indicate a systemic failure to ensure the identity, purity, strength, and composition of their dietary supplements.