FDA 483 - Calvin Scott & Company, Inc. - March 12, 2020

Calvin Scott & Company, Inc. in Albuquerque, NM, a drug repackager and relabeler, was inspected by the FDA from March 9-12, 2020. The inspection revealed significant deficiencies across its quality system, facilities, equipment, and packaging/labeling controls, including a non-existent quality control unit, inadequate cleaning and maintenance, and lack of proper procedures for stability testing, change control, and deviation investigations. Several observations were repeats from a previous inspection, indicating persistent non-compliance.