FDA WARNING_LETTER - UCSF Radiopharmaceutical Facility - July 24, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to the UCSF Radiopharmaceutical Facility following an inspection conducted from July 21 to 24, 2025. The document details several significant violations of Current Good Manufacturing Practice (CGMP) regulations, which define the facility"s drug products as adulterated under the Federal Food, Drug, and Cosmetic Act.

Key issues identified during the inspection include the facility"s failure to conduct thorough investigations into sterile batch failures. Specifically, the facility frequently dismissed positive sterility test results as laboratory errors without scientific proof, potentially overlooking contamination in the manufacturing process. The facility also failed to follow its own quality assurance protocols, as evidenced by a lack of investigation into adverse environmental trends and a massive backlog of unresolved quality issues—some remaining open for over 1,000 days. Furthermore, investigators noted improper cleaning practices and a lack of environmental monitoring in critical production areas, which could lead to undetected microbial contamination. Finally, the firm failed to submit required reports to the FDA regarding product quality defects.

To resolve these violations, the FDA requires UCSF to provide a comprehensive remediation plan, including an independent, retrospective review of all invalidated sterility tests from the past three years. The facility must also submit updated environmental monitoring procedures and a plan to improve quality unit oversight. The FDA strongly recommends that the facility hire a qualified consultant to assist in meeting regulatory requirements. A written response outlining all corrective actions is required within 15 working days.