Nexus Pharmaceuticals Inc – FDA EIR, Jan 20, 2023

An FDA pre-approval inspection was conducted at Nexus Pharmaceuticals Inc.'s new manufacturing facility in Pleasant Prairie, WI, from January 9 to January 20, 2023. The inspection, conducted under FDA's Preapproval Inspection and Drug Quality Assurance programs, aimed to assess readiness for commercial manufacturing of terminally sterilized small volume parenterals, including Sterile Water for Injection, Potassium Chloride for Injection Concentrate, and Sodium Chloride Injection. The inspection resulted in four significant observations detailed in an FDA Form 483, indicating deviations from Good Manufacturing Practices regulations, such as 21 CFR 211. These included: inadequate handling and storage of components, specifically rejected materials; accepting supplier certificates of testing for containers and closures without independent validation; absence of proper written procedures for production and process controls, exemplified by uncontrolled issuance of electronic batch record worksheets; and insufficient controls over computer systems to ensure only authorized personnel institute changes to master records. Additionally, eight verbal discussions highlighted further concerns, including incomplete theoretical yield documentation, unlabeled materials, inadequate visual inspection protocols, un-packaged exhibit and stability samples, unfinalized potent compound procedures, non-comprehensive corrective action reviews, and accepting curricula vitae as proof of training proficiency. Nexus Pharmaceuticals Inc. committed to implementing corrective actions for all identified issues and will submit a written response to the FDA within 15 business days. The FDA recommended partial approval for the commercial manufacturing of terminally sterile products, pending resolution of the noted deficiencies, particularly regarding validated packaging and labeling operations.