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

ANI Pharmaceuticals, Inc. underwent an FDA surveillance drug manufacturing inspection in Baudette, MN, from November 14-18, 2022. The inspection, conducted under compliance program 7356.002, identified several deficiencies in adherence to Good Manufacturing Practices (GMP) across quality, materials, and packaging/labeling systems. Classified as Voluntary Action Intended (VAI), the inspection resulted in an FDA Form 483 with six observations and a verbal observation. Main violations included a failure to thoroughly investigate product discrepancies and implement timely corrective actions. ANI notably delayed investigating a recurring trend of short-count complaints for Diphenoxylate/Atropine tablets and failed to apply corrective actions after multiple employees overlooked an incorrect expiration date on Morphine Sulfate Oral Solution bottles. Procedures for production and process control were not consistently followed, as demonstrated by undocumented investigations and corrective actions for environmental control system alarms (Level I and II) related to temperature and humidity in manufacturing areas. The company also did not adjust its component inspection sampling plans after discovering persistent supplier defects, such as holes in Mesalamine Rectal Suspension Enema bottles. Additionally, ANI's policy was to only provide complaint responses to complainants when requested. A verbal observation highlighted the poor condition of manufacturing facility floors, with cracked and peeling epoxy. ANI management acknowledged these findings and committed to providing a written response. The company was reminded of its obligations under the Federal Food, Drug, and Cosmetic Act, with potential for significant enforcement actions if non-compliance continues.