FDA EIR - Haupt Pharma Wuelfing GmbH - December 07, 2018

An FDA routine surveillance Good Manufacturing Practice (GMP) inspection of Aenova Haupt Pharma Wulfing GmbH, located in Gronau (Leine), Germany, was conducted from November 29 to December 7, 2018. This comprehensive inspection, guided by Compliance Programs 7371.001 and 7356.002, covered various systems including quality, facilities, equipment, materials, production, packaging, labeling, and laboratory controls. The primary focus was on the company’s manufacturing of tablets shipped to the U.S. market, with a limited review of terminally sterilized products not yet distributed in the U.S. Significantly, the inspection concluded with no Form FDA 483 Inspectional Observations issued, indicating no new deficiencies were identified during this review. The report also highlighted that the firm had successfully addressed all seven observations raised during a previous pre-approval inspection in August 2018. These prior issues concerned aspects like quality control unit responsibilities, facility design to prevent contamination, supplier material reliability, temperature/humidity control, completeness of master production records, yield determination, and in-process material testing procedures. All previously required corrective actions were reviewed and found to be sufficiently implemented. This outcome affirms the company's adherence to regulatory standards for drug manufacturing at the time of this inspection.