FDA EIR - Fresenius Kabi USA, LLC - March 06, 2015

An FDA Pre-Approval Inspection of Fresenius Kabi USA, LLC, a sterile drug manufacturer in Grand Island, NY, was conducted from February 24 to March 6, 2015. The inspection, pursuant to a New Drug Application (NDA), aimed to assess the firm's readiness to manufacture a specific drug product, operating under Good Manufacturing Practice (GMP) regulations.The inspection resulted in an FDA-483, Inspectional Observations, with two formal findings. The first observation cited deficiencies in determining actual and theoretical yields at manufacturing phases, specifically lacking established acceptable yields for bulk material and incomplete documentation of product loss during filling. Furthermore, no full-scale batches had been produced to confirm process capability for the new product. The second observation highlighted inadequate environmental monitoring in aseptic processing areas, where re-testing of particle counts was permitted without justification for invalidating original results, potentially masking adverse trends.Beyond these formal observations, the FDA verbally discussed three additional areas with management. These included incomplete information regarding the finished product's moisture content test method and specifications, the firm’s overall readiness to manufacture the new product (including issues with batch record clarity and operator adherence to instructions), and the general approach to equipment re-validation, suggesting current methods using only worst-case locations might be insufficient for full validation.Fresenius Kabi management committed to formally respond to the FDA-483 within fifteen business days and to address the verbally discussed conditions by assessing procedures, implementing improvements, conducting necessary performance qualification batches, and re-evaluating equipment re-qualification strategies.