FDA 483 - Calvin Scott & Company, Inc. - June 19, 2023

Calvin Scott & Company, Inc. in Albuquerque, NM, a repackager and relabeler, received a Form 483 with five observations. The inspection revealed significant deficiencies in quality unit responsibilities, annual product review procedures, employee cGMP training, and equipment maintenance and qualification. Several observations were repeats from previous inspections, indicating persistent issues.