FDA 483 - Curia Global, Inc. - July 09, 2025

An FDA Form 483 was issued to CURIA GLOBAL INC, an API Manufacturer in Albany, NY, following an inspection conducted from May 5-9, 2025. The inspection highlighted several compliance issues indicating deviations from Current Good Manufacturing Practices (CGMP). Key observations included a persistent failure to maintain clean facilities, specifically noted by recurring live mice activity near the production area from 2019 to 2025. The firm also failed to demonstrate that its manufacturing process for a commercially distributed excipient consistently meets quality attributes, lacking adequate procedures and data for process control. Additionally, the quality unit did not ensure sufficient scientific-based stability data to support the assigned retest or expiry dates for various excipients and intermediates produced between 2019 and 2025. Furthermore, a dedicated glass reactor used in excipient manufacturing was found to be unqualified. These findings necessitate a comprehensive response from CURIA GLOBAL INC, detailing the corrective and preventive actions to address these observations and ensure regulatory compliance and product integrity.