FDA 483 - Ascent Pharmaceuticals Inc - August 09, 2024

During an inspection conducted from August 1 to August 9, 2024, the FDA issued a Form 483 to Ascent Pharmaceuticals Inc., a drug manufacturer located in Central Islip, NY. The inspection revealed several significant deviations from Current Good Manufacturing Practices (CGMP) intended to ensure the safety, identity, strength, quality, and purity of drug products.

Key observations included inadequate cleaning and maintenance of manufacturing equipment. Inspectors found residual white powder on balances and residue within a double cone blender, despite both being labeled as 'cleaned.' Furthermore, a dirty hold time study was deemed insufficient, and critical air flow control components lacked established cleaning procedures.

The FDA also identified issues with data integrity and computer system controls. An analytical balance in the QC laboratory lacked password protection for time and date modifications, potentially compromising GMP documentation. The Quality Control electronic data audit trail review process was found deficient, lacking requirements for system audit trail reviews, checks for deleted data, and instructions for standalone equipment audit trail assessments.

Additional observations included a failure to perform routine performance checks on automatic equipment, specifically the calibration of a capsule encapsulation machine. Finally, the company failed to thoroughly investigate an unexplained discrepancy involving a significantly lower yield for a manufacturing batch of capsules. Ascent Pharmaceuticals Inc. is required to submit a comprehensive response detailing its corrective and preventive actions to address these regulatory deficiencies.