ANI Pharmaceuticals, Inc. – FDA 483, Nov 18, 2022

ANI Pharmaceuticals, Inc. in Baudette, MN, was inspected by the FDA from November 14-18, 2022, resulting in a Form 483 with six observations. The inspection revealed significant deficiencies in quality control, production procedures, sanitation, and complaint handling. Key issues included inadequate investigations into product discrepancies, failure to follow environmental control SOPs, and improper container testing.