FDA 483 - ANI Pharmaceuticals, Inc. - December 02, 2024

The FDA conducted an inspection of ANI Pharmaceuticals Inc., located at 210 Main St, West, Baudette, MN, from December 2 to December 6, 2024. The inspection revealed several critical observations related to the company's drug manufacturing practices.

Key violations included inadequate cleaning of equipment, specifically the Fluid Bed Dryer, which showed contamination with Propafenone Hydrochloride, potentially affecting product safety and quality. Additionally, the firm failed to verify the identity of each drug component using specific tests, particularly for raw materials like Glycerin and Propylene Glycol, which are crucial for ensuring product integrity.

The inspection also noted that written procedures for equipment cleaning and maintenance were not consistently followed, as evidenced by powder build-up in mixing rooms. Furthermore, ANI Pharmaceuticals lacked proper supplier qualification processes, particularly for Thyroid API suppliers, which could compromise the quality of Thyroid Tablets released to the market.

The FDA requires ANI Pharmaceuticals to address these issues by implementing corrective actions, such as enhancing cleaning protocols, establishing robust identity verification processes for raw materials, ensuring adherence to written procedures, and completing supplier qualifications with signed quality agreements. These actions are necessary to comply with regulatory standards and ensure the safety and efficacy of their drug products.