FDA EIR - Afton Scientific, LLC - June 14, 2019

An FDA inspection of Afton Scientific LLC, a contract manufacturer of sterile human and animal drug products, was conducted from June 11-14, 2019. This routine comprehensive inspection followed Compliance Program Guidance Manuals 7356.002, 7356.002A, 7371.001, and applied Title 21 of the Code of Federal Regulations parts 210 and 211, which govern drug manufacturing. The inspection focused on the firm's quality, materials, production, and laboratory systems. A seven-item Form FDA 483, "Inspectional Observations," was issued. Key violations included inadequate validation of aseptic processes, particularly concerning filler control adjustments and the lack of historical trend analysis for interventions. Laboratory controls were found deficient, lacking scientifically sound sampling plans and test procedures, such as for environmental monitoring for yeast and molds. Drug products were not stored under appropriate temperature conditions. Furthermore, the quality control unit's responsibilities were not fully documented or followed, and electronic records failed to meet trustworthiness and reliability standards

—a repeat observation from the previous 2017 inspection. There were also inadequate separate areas to prevent contamination in aseptic processing, and the firm failed to thoroughly investigate unexplained discrepancies and batch failures, another repeat observation. Finally, laboratory records lacked sufficient detail regarding samples. Afton Scientific's management acknowledged the observations and committed to providing a written response with corrective actions within 15 business days.