UCSF Radiopharmaceutical Facility

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to conduct adequate investigations and take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications. (21 CFR (b)(4)).

Passage 2

Your firm failed to thoroughly evaluate whether this and other batch sterility test failures were caused by deficient aseptic manufacturing practices. Notably, your facility has experienced multiple recoveries of spore-forming organisms in sterility samples and production environments.

Passage 3

Your firm failed to follow written quality assurance procedures. (21 CFR (b)(4)).

Passage 4

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.