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

Azurity Pharmaceuticals, Inc. underwent an FDA inspection from February 14 to February 24, 2022. This pre-announced, for-cause inspection, conducted at their Wilmington and Woburn, MA facilities, was requested by the Division of Drug Quality II and followed Compliance Program 7356.002 for Drug Process Inspections, focusing on non-sterile powders. The inspection covered quality, facilities, equipment, materials, production, packaging, labeling, and laboratory systems for products like Firvanq, FIRST Omeprazole, and others. During the inspection, the FDA issued a Form FDA 483, highlighting three significant observations. First, the firm exhibited inadequate cleaning of its sampling booth, with unknown powder residues observed on an air intake vent. Second, there was inadequate sampling of bulk active pharmaceutical ingredients (APIs). Third, the company failed to conduct periodic verification testing of its fill lines to ensure the effectiveness of validated cleaning processes, particularly after introducing additional products to previously dedicated lines. Corrective actions for deficiencies identified in a previous 2019 pre-approval inspection, which included lack of data for microbiological testing and inadequate complaint investigations, were verified as complete during this visit. The current 483 observations require a formal response and remedial actions from Azurity Pharmaceuticals.