FDA 483 - U.S. Continental Marketing, Inc. - July 21, 2022

U.S. Continental Marketing, Inc. in Corona, CA, was inspected and cited for multiple deficiencies across its quality control, personnel training, labeling, and equipment systems. The inspection revealed a lack of written procedures, inadequate training records, uncontrolled label storage, and unperformed equipment qualifications, indicating significant non-compliance with cGMP regulations. These issues collectively point to a systemic failure in maintaining proper controls for drug product manufacturing.