FDA 483 - Corden Pharma Colorado, Inc. - February 06, 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.