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UCSF Radiopharmaceutical Facility CGMP Violations Warning Letter

FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter to UCSF Radiopharmaceutical Facility on April 13, 2026, citing significant Current Good Manufacturing Practice (CGMP) violations discovered during a July 21-24, 2025 inspection. The agency found that drug products manufactured at the facility are adulterated under Section 501(a)(2)(B) of the FD&C Act due to inadequate investigations of sterility test failures and failure to follow written quality assurance procedures.