FDA 483 - Ionetix Corporation - September 14, 2023

An FDA inspection of Ionetix Corporation, a PET Drug Manufacturer located in El Paso, TX, was conducted from September 11-14, 2023. The inspection resulted in the issuance of an FDA Form 483, detailing two significant observations under the Federal Food, Drug, and Cosmetic Act. The primary issues relate to inadequate contamination control measures and deficiencies in laboratory testing procedures. Specifically, the FDA observed that the firm is not performing viable surface sampling within the ISO 5 hood where sterile PET drug products are filled into syringes, raising concerns about potential product contamination. Additionally, Ionetix Corporation has not validated the incubation temperature and time for media used in environmental and personnel monitoring during production and sterility testing, indicating a lack of robust quality control. As an FDA 483 report, these observations do not represent a final compliance determination but necessitate the firm to address these conditions. Ionetix Corporation is expected to develop and implement comprehensive corrective actions to ensure proper contamination prevention and validate all critical laboratory testing procedures to comply with Good Manufacturing Practices and safeguard product quality and patient safety.