FDA EIR - Haupt Pharma Wolfratshausen GmbH - February 14, 2020

An FDA pre-approval inspection (PAI) was conducted at Haupt Pharma Wolfratshausen GmbH from February 10 to 14, 2020. The inspection's primary objectives were to evaluate the firm's readiness for commercial manufacturing, conformance to its drug application, and data integrity for a new non-sterile liquid drug product. This was performed under the guidance of CPGM 7346.832.A prior FDA inspection in October 2017 had cited three observations related to quality control unit responsibilities, justification of deviations, and proper drafting and approval of written procedures. During the 2020 inspection, all these previously identified issues were confirmed to be corrected.The current inspection covered six key systems, including quality, facilities, equipment, materials, production, and laboratory operations. No Form FDA-483, Inspectional Observations, was issued. A single minor item was discussed with management, who expressed willingness to make voluntary corrections. The inspection concluded with a "No Action Indicated" (NAI) classification, and the FDA Office of Regulatory Affairs recommended approval of the pre-approval inspection for the facility.