FDA 483 - Azurity Pharmaceuticals, Inc. - February 24, 2022

An FDA inspection of Azurity Pharmaceuticals, Inc. in Wilmington, MA, identified significant deficiencies across three observations. The firm failed to adequately clean equipment, specifically a sampling booth, and lacked proper sampling procedures for active pharmaceutical ingredients. Additionally, the company did not verify cleaning validation for fill lines after introducing new products, indicating potential risks to drug product quality and purity.