'Sterility failures' prompt FDA to threaten radiopharmaceutical producer with disciplinary action
A radiopharmaceutical manufacturer in California recently received a stern warning from the U.S. Food and Drug Administration due to sterility issues discovered during an inspection.
According to an FDA warning letter, multiple issues that could raise the risk of product contamination were uncovered last summer at the University of California San Francisco (UCSF) Radiopharmaceutical Facility. The letter details “significant violations” with respect to sterility test failures.
The UCSF facility manufactures numerous radiopharmaceutical agents used during PET imaging exams. The investigation was related to reports from a prior sterility failure that revealed a tube included in a batch was contaminated with a microorganism identified as Bacillus species, a gram-positive spore-forming bacterium. No laboratory failures were identified, and the facility determined that the bacteria were likely introduced to the test tube during sterility testing.
The FDA’s letter suggests that the facility’s efforts to determine whether the contamination was a one-off or was due to deficient aseptic manufacturing practices were not adequate. What’s more, the letter indicates that the facility has reported numerous discoveries of bacteria during sterility testing procedures.
“Your response is inadequate because there remains a lack of compelling evidence that the sterility failures were attributable to laboratory contamination,” the FDA said in its letter. “Your belief that media must both exhibit growth and if they do not, the test should be considered a false positive, fails to recognize that each medium possesses unique sensitivities, limitations, and growth capabilities."
As the FDA was not satisfied with the facility’s response to its concerns, the agency is requiring UCSF to conduct a thorough assessment of its sterility practices and provide a detailed plan of action describing actions it is taking to remedy the issues and prevent them from occurring in the future.
“Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction,” the letter warned. "Unresolved violations may also prevent other federal agencies from awarding contracts.”
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.