FDA 483 - Corden Pharma Colorado, Inc. - June 28, 2013

An FDA inspection of Cordon Pharma Colorado, Inc. in Boulder, CO, an API manufacturer, revealed significant deficiencies in quality control, facility maintenance, and adherence to internal procedures. Observations included a lack of thorough investigation into out-of-specification incidents, unsanitary conditions in the raw material sampling room, and failures to follow incident reporting and investigation protocols.