FDA 483 - U.S. Continental Marketing, Inc. - October 30, 2018

An FDA inspection of U.S. Continental Marketing, Inc., a contract OTC drug product labeler in Corona, CA, revealed significant deficiencies in their current good manufacturing practices. The firm failed to provide cGMP training to employees, maintain accurate batch production and control records, and adequately control drug product labeling operations. Additionally, the inspection found that written procedures for component handling were not followed, distribution records lacked essential lot numbers, and equipment maintenance and cleaning records were not kept.