FDA 483 - Curium US PET LLC - April 18, 2025

During an inspection conducted from April 14-18, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Curium US LLC, a drug substance and drug product manufacturer located in Noblesville, Indiana. The inspection revealed significant concerns regarding the company's adherence to quality manufacturing standards. Key observations included multiple deficiencies in data integrity and control over computer systems. Analysts and R&D personnel were found to have excessive access privileges, including "superuser" roles in critical HPLC systems, allowing unrestricted data manipulation. Furthermore, pH meters lacked essential user account and password protection, and raw data from these devices were not electronically backed up. The Quality Assurance unit's review of manufacturing batch records was limited to paper documentation, failing to include verification of electronic data, audit trails, or critical process parameters. Additionally, laboratory equipment logbooks were not maintained in a secure, hard-bound format, compromising data reliability. The FDA also noted that seven out-of-specification laboratory investigations, spanning from June 2024 to February 2025, concerning failures in growth promotion testing of media, were inadequate in preventing recurrence. While the company initiated corrective actions to update procedures, the recurring nature of these issues suggests a need for more comprehensive root cause analysis. Finally, procedures intended to prevent microbiological contamination of sterile drug products were identified as not fully established or followed. Curium US LLC is required to implement thorough corrective and preventive actions to address these observations and ensure compliance with regulatory expectations.