FDA 483 - Nielsen BioSciences, Inc. - April 17, 2025

During an FDA inspection conducted from April 8 to April 17, 2025, a pharmaceutical firm received an FDA Form 483 detailing significant observations concerning its adherence to regulatory requirements for drug manufacturing. Key issues highlighted a systemic breakdown in the firm's quality management system. The inspection revealed a failure to maintain comprehensive records for annual product reviews, with several years of data from the Contract Manufacturing Organization (CMO) lacking proper review and documentation. The quality control unit exhibited several deficiencies, including the untimely closure of 34.5% of deviations, with some outstanding for over 250 days, and delayed initiation of critical deviations. Corrective and Preventive Actions (CAPAs) were also not closed promptly, some being overdue by more than 447 days. Furthermore, the firm had not validated its external logistics provider's capability to maintain required temperatures for sensitive biologic products during shipping. Other observations included a failure to thoroughly investigate unexplained discrepancies, such as a significant environmental monitoring system interruption where product storage temperatures were not recorded and no comprehensive quality impact assessment was conducted. The firm was found to have inadequate qualified personnel, with only one individual trained for critical potency release and stability testing for specific drug products, lacking an alternate. Production and process control procedures were not consistently followed, as evidenced by inventory records for GMP materials not being submitted for Quality Assurance review. Finally, the firm lacked established written procedures for identifying, evaluating, and reporting biological product deviations. The company is required to promptly address these observations with robust corrective actions to ensure compliance with Good Manufacturing Practices.