FDA EIR - NCM USA LLC - December 08, 2017

An FDA inspection of NCM USA Bronx LLC, a manufacturer of Positron Emission Tomography (PET) drugs, was conducted from November 30 to December 8, 2017. The inspection, guided by Good Manufacturing Practices (GMP) regulations for PET drugs, revealed several significant deficiencies, leading to the issuance of an FDA-483 with five observations and additional verbal observations. Key issues included the continued use of a depyrogenation oven after it failed calibration due to a faulty fan motor, indicating inadequate equipment maintenance procedures. Laboratory controls were found deficient, with expired microorganisms used for testing and insufficient documentation, compromising test validity. The company also failed to maintain accurate component weight documentation in master production records for reagent preparations. Furthermore, NCM USA Bronx LLC implemented unapproved changes to existing drug specifications and testing methods, such as removing a required impurity test and altering an acceptance criterion for Sodium Fluoride F-18 without proper justification or notification to the FDA. Finally, the inspection noted a failure to follow written quality assurance procedures, specifically regarding environmental monitoring, where required particle count data was not captured, and viable air sampling was omitted during cleanroom certifications. Management acknowledged these observations and committed to submitting a formal written response to the FDA within 15 business days.