483
U.S. Continental Marketing, Inc.FDA 483 - U.S. Continental Marketing, Inc. - July 21, 2022
Record Details
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.
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ID · bb1ac4d7-f137-4025-9bc2-c11a200c1319