FDA 483 - Division of Nuclear Medicine PET Radiopharmaceutical Production Program - September 17, 2025

The Division of Nuclear Medicine PET Radiopharmaceutical Production Program received an FDA Form 483 following an inspection conducted on September 16-17, 2025. The document details significant deficiencies in the firm's manufacturing processes, quality assurance, and regulatory reporting for PET drug products.Key violations centered on inadequate production and process controls. Inspectors observed a lack of appropriate parameters for investigating microbial growth, with procedures requiring investigations only above a certain microbial count. Environmental monitoring protocols were found deficient, specifically not requiring surface contact plating in critical sterile environments like the Biological Safety Cabinet where sterility media is handled. Gowning and cleaning procedures were also inadequate, failing to mandate sterile gloves and prevent human hair and skin exposure in ISO-classified areas, with direct observations of non-sterile glove use and exposed hair during product assembly.Furthermore, the facility failed to adhere to its own written quality assurance procedures by not conducting thorough investigations into noted microbial excursions, performing only identification without implementing corrective or preventive actions. A critical regulatory lapse involved the firm's failure to submit Field Alert Reports to the FDA within three working days regarding suspected bacteriological contamination in distributed sterile PET drug products. The firm also lacked documented procedures for submitting these essential reports.These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, indicate conditions that could lead to the production of adulterated drugs. The firm is expected to promptly address these findings by implementing comprehensive corrective and preventive actions to ensure the consistent production of safe and quality radiopharmaceutical products and comply with federal regulations.