API Deviations Seen in Fagron Group Inspection

An 11/1-11/18/21 FDA inspection at the Fagron, Inc., drug manufacturing facility in St. Paul, MN, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 6/14 Warning Letter says specific violations were:

• failing to perform repackaging of API under appropriate CGMP to avoid potential cross-contamination;
• failing to adequately investigate and document out-of-specification results and implement appropriate corrective actions; and
• failure of the firm’s quality unit to exercise its responsibility to ensure the APIs manufactured at the facility comply with CGMP.

FDA strongly recommends the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. Fagron was told to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.