FDA 483 - Aspen Co-Pak, LLC - April 14, 2016

An FDA inspection of Aspen Co-Pak, LLC in Lindon, UT, a dietary supplement and food manufacturer, revealed ten significant observations, many of which were repeat findings from a previous inspection. The firm failed to establish critical specifications for components and finished products, did not perform identity testing, and lacked proper quality control procedures and batch record documentation. Additionally, the facility exhibited unsanitary conditions and lacked procedures for returned dietary supplements, indicating systemic deficiencies in their manufacturing practices.