FDA 483 - Ionetix Corporation - February 06, 2025

An FDA inspection of Ionetix Corporation, a PET Drug Product Manufacturer located in Knoxville, TN, conducted from February 3-6, 2025, resulted in the issuance of a Form FDA 483. This document outlined significant inspectional observations indicating deviations from current Good Manufacturing Practices. The primary issues included the firm's failure to adequately qualify a supplier for a critical precursor, raising concerns about the consistent quality, strength, and safety of incoming materials. Ionetix also lacked established written procedures for the proper handling and storage of components, specifically regarding temperature control during shipping and receipt of critical precursors. Further observations noted the company's non-adherence to its own procedures for the examination, approval, or rejection of components before use, and a deficiency in conducting identity testing for inactive ingredients within PET drug products. Moreover, the inspection highlighted inadequate equipment management, including missing preventive maintenance procedures and a failure to follow established testing schedules. Finally, inconsistencies were identified within the firm’s written quality assurance procedures for environmental monitoring, specifically regarding action limits and incubation parameters for classified manufacturing areas. Ionetix Corporation is expected to provide a comprehensive response detailing corrective and preventive actions to address these observed deficiencies and ensure compliance with regulatory standards.