Corden Pharma Colorado, Inc. – FDA 483, Feb 6, 2019

Corden Pharma Colorado, Inc. in Boulder, CO, an Active Pharmaceutical Ingredient Manufacturer, was inspected by the FDA from January 30 to February 6, 2019. The inspection revealed a significant issue regarding the firm's quality control procedures, specifically the failure to justify deviations from written test procedures for microbiological media and to properly qualify media suppliers. This indicates a lack of adequate controls over critical laboratory processes and materials.