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

An FDA inspection of Azurity Pharmaceuticals, Inc., located in Wilmington and Woburn, MA, took place from February 14 to February 24, 2022. This pre-announced inspection, initiated by the Division of Drug Quality II Compliance Branch under Compliance Program 7356.002A, focused on the company's manufacturing and distribution of non-sterile powder prescription compounding kits, including products such as Firvanq and FIRST Omeprazole. The regulatory framework aimed to ensure adherence to good manufacturing practices for these drug products. The inspection resulted in three main observations documented on a Form FDA 483. These issues included inadequate cleaning practices within the firm's sampling booth, evidenced by unknown powder residues; insufficient sampling procedures for bulk active pharmaceutical ingredients; and a failure to conduct periodic verification testing of the fill line cleaning processes. This latter observation was particularly critical as it occurred after the introduction of additional products to lines previously dedicated to single products, potentially impacting cleaning effectiveness. Azurity Pharmaceuticals is required to address these deficiencies by implementing comprehensive corrective and preventive actions to ensure ongoing compliance and maintain drug product quality.