FDA 483 - U.S. Continental Marketing, Inc. - March 18, 2021

U.S. Continental Marketing, Inc., a repacker and relabeler in Corona, CA, was cited for multiple significant deficiencies during an FDA inspection. Observations included a lack of stability data for expiration dates, inadequate quality control unit procedures, insufficient employee training, poor label control, and failures in equipment cleaning and qualification. These issues indicate a systemic lack of adherence to good manufacturing practices.