FDA 483 - Huvepharma, Inc. - April 23, 2019

Huvepharma, Inc. in Longmont, CO, was inspected and cited for significant deficiencies in its quality control unit's responsibilities and procedures, particularly regarding document control and contractor oversight. The inspection also revealed a failure to thoroughly investigate product discrepancies and inadequate raw material sampling procedures. These issues indicate a systemic lack of robust quality management and could impact product quality and control.