FDA 483 - Pharbil Waltrop Gmbh - February 14, 2020

An FDA inspection of Pharbil Waltrop Gmbh in Waltrop, Germany, revealed significant deficiencies in manufacturing process controls. The firm failed to establish adequate control procedures for monitoring manufacturing processes, including insufficient drug product sampling plans and uncontrolled labels for samples. Additionally, the company did not determine actual or theoretical yields at the conclusion of manufacturing phases, hindering the recognition and investigation of production deviations.