FDA EIR - Ascent Pharmaceuticals Inc - October 13, 2020

A comprehensive Current Good Manufacturing Practices (CGMP) and Pre-Approval Inspection (PAI) of Ascent Pharmaceuticals, Inc. in Central Islip, NY, was conducted by the FDA between September 17 and October 13, 2020. The inspection evaluated the firm's manufacturing of human drug products and its role in an Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended Release Tablets. The inspection revealed four significant observations documented in an FDA-483. Main violations included inadequate controls over computer systems for master production and control records, failure to consistently follow written production and process control procedures, insufficient review of unexplained discrepancies (even for distributed batches), and the storage of drug products under inappropriate humidity conditions, potentially compromising their identity, strength, quality, and purity. Additional issues noted were the premature closure of change controls and deficiencies in the Corrective and Preventive Action (CAPA) system regarding tracking and effectiveness checks. Ascent Pharmaceuticals' President & CEO, Mr. Sudhakar R. Vidiyala, acknowledged the observations and committed to providing a written response to the FDA-483 within 15 working days.