University of Iowa Pharmaceuticals (UIP) – FDA EIR, May 4, 2018

The FDA conducted a comprehensive inspection of University of Iowa Pharmaceuticals (UIP), a small-scale contract manufacturer, from April 30 to May 4, 2018. The inspection, covering sterile and non-sterile drug manufacturing, was performed under established drug manufacturing and sterile drug process compliance programs, emphasizing adherence to Current Good Manufacturing Practices. Upon conclusion, the FDA issued a Form 483 with four significant observations. Key issues included UIP's failure to scientifically justify the use of expired or near-expiration raw materials, and inadequacies in the testing methodology for employee visual acuity. Furthermore, the inspection identified that media fills did not adequately simulate actual production processes for their commercial sterile drug product. A critical finding was UIP's failure to report adverse reaction complaints to the FDA, despite receiving three such reports from a client. Additionally, verbal warnings were issued regarding the lack of qualification for ISO 5 cleanrooms after modifications, absence of procedures for drug product reprocessing, prolonged timelines for visual inspector requalification, delayed incident report generation, and untimely closure of investigations into discrepancies. UIP was required to submit a written response to the FDA 483 observations within 15 business days, outlining corrective actions and adherence to regulatory standards. Management was also advised to conduct internal audits to ensure overall compliance.