FDA 483 - Nexus Pharmaceuticals Inc - January 20, 2023

An FDA inspection of Nexus Pharmaceuticals Inc in Pleasant Prairie, WI, a manufacturer and packager of drug products, revealed significant deficiencies. Observations included inadequate handling and storage of rejected components, failure to validate supplier test results for stoppers, and a lack of proper controls over electronic batch records and computer systems, including shared login credentials. These issues indicate a need for improved quality control and data integrity practices.