FDA 483 - Curtis Jacquot dba Pacific BioLogic Co. - January 31, 2018

During an inspection, Pacific Biologic Co., a dietary supplement own-label distributor in Concord, CA, was cited for failing to establish and verify product specifications for its finished dietary supplements. The firm did not have specifications for purity and composition, nor did it verify that finished batches met identity and strength specifications. These are repeat observations, indicating persistent quality control issues.