FDA EIR - Lonza Biologics, Inc. - November 03, 2020

An FDA pre-approval inspection of Lonza Biologics Inc. in Portsmouth, NH, was conducted from October 28 to November 3, 2020. The inspection focused on the manufacturing of a therapeutic drug substance, assessing Quality, Facilities and Equipment, Production, Materials, and Laboratory Control Systems, in accordance with FDA compliance policies (CP 7356.002M, CP 7346.832) and ICH Q7 guidelines. At the conclusion of the inspection, a 3-item Form FDA 483 was issued to the site head, detailing significant objectionable conditions. Key violations included the inadequate qualification of a utility used in manufacturing. Additionally, deficiencies were noted in the proper installation and maintenance of manufacturing equipment and facilities; specifically, issues like inadequate air breaks, leaks from bioreactor connections and water for injection (WFI) systems, and deteriorated structural sealants were observed. The inspection also identified failures to follow or inadequate Standard Operating Procedures (SOPs) and work instructions, exemplified by incomplete logbook documentation, a lack of procedures for storing small loose materials, and non-adherence to equipment operational protocols, such as those for the Gold Particle Tester. Lonza Biologics Inc. is now required to address these observations with comprehensive corrective and preventive actions to ensure full compliance with regulatory standards.