FDA 483 - Antares Pharma, Inc - December 04, 2018

Antares Pharma, Inc. in Minneapolis, MN, was inspected by the FDA from November 27 to December 4, 2018. The inspection revealed that corrective and preventive action activities were not adequately documented. Specifically, Supplier Corrective Action Requests (SCARs) lacked proper documentation of actions and verification of effectiveness.