AGC Biologics A/S – FDA EIR, Nov 7, 2017

An FDA Level I Good Manufacturing Practice (GMP) inspection of CMC Biologics A/S, a biological product manufacturer located in Soeborg, Copenhagen, Denmark, was conducted from October 30 to November 7, 2017. The inspection, performed under the regulatory framework of CP 7345.848 for Biological Drug Products, comprehensively evaluated the firm's Quality, Production, Facilities & Equipment, and Laboratory Control Systems. CMC Biologics A/S functions as a contract manufacturer for an intermediate drug substance, which is subsequently shipped for further processing into a final drug product.

The thorough assessment included a review of annual product quality reviews, deviation reports, laboratory investigation reports, manufacturing processes, batch production records, process validation, release specifications, analytical data, quality agreements, customer complaints, corrective and preventative actions, change controls, stability data, and raw material management. Significantly, at the conclusion of the inspection, an FDA-483, 'List of Inspectional Observations,' was not issued. This indicates that no significant deficiencies or objectionable conditions were identified. Consequently, no specific regulatory violations or issues were noted, and no immediate corrective actions were formally required by the FDA. The final classification of the firm will be determined by the Center for Biologics Evaluation and Research (CBER) after a complete review of the Establishment Inspection Report.