Nana Barseghian, M.D. – FDA 483, Feb 9, 2024

An FDA inspection of Amneal Pharmaceuticals of New York, LLC, conducted from January 22 to February 9, 2024, resulted in the issuance of a Form FDA 483 detailing eight significant observations. The findings primarily highlight deficiencies in the company's adherence to Current Good Manufacturing Practice (CGMP) regulations, specifically outlined in 21 CFR Part 211. Several critical issues were identified, many of which are repeat observations from previous inspections. Aseptic processing for sterile drug products, particularly Vancomycin for Injection, USP, was found to be inadequately validated, with multiple media fills yielding unacceptable contamination rates and failing to represent routine manufacturing conditions. The firm also demonstrated a lack of appropriate controls over computer systems, enabling IT administrators to alter or delete raw data without an audit trail, raising data integrity concerns. Further observations included failures to document manual interventions during aseptic filling in batch records and inadequate adherence to quality control procedures for documenting interventions and environmental monitoring deviations. The inspection also noted deficient cleaning and disinfection practices in aseptic processing areas, presence of residues, uncalibrated particle counters, and uncertified HEPA filters. Additionally, personnel were observed not following standard test methods for drug product release. Amneal Pharmaceuticals is required to address these serious observations promptly by implementing comprehensive corrective and preventive actions to ensure compliance and product quality.