FDA 483 - Ionetix Corporation - September 26, 2025

An FDA Form 483 was issued to a Positron Emission Tomography (PET) drug manufacturer in Miami Beach, FL, following an inspection conducted from September 22-26, 2025. The inspection revealed several significant deviations from federal manufacturing quality standards. Key violations included a systemic failure to adhere to written quality assurance procedures, specifically regarding supplier qualification for a critical component used in PET drug production. A vendor supplying this component was not registered with the FDA, impacting numerous patient and validation batches. Equipment suitability and maintenance were also cited as inadequate. Obstructions within an ISO 5 laminar flow hood compromised its sterile environment, affecting commercial product integrity. Additionally, the firm lacked documented procedures for managing critical equipment during power outages, notably concerning a system to prevent a 'quench' event, and possessed no backup generator or designated on-site emergency team leader. Furthermore, the company failed to follow its own written procedures for testing components and drug product containers. Specifically, required shielding for radiochemical identity and purity testing was absent during laboratory operations. Facility contamination control was found deficient, with inappropriate cleaning tools stored in a cleanroom and a lack of investigation into microbial contamination detected in a critical ISO 5 hood. The observations necessitate prompt corrective actions to ensure the safety, quality, and purity of PET drugs manufactured at the facility and to comply with federal regulations.