Cardinal Health 414, LLC – FDA 483, Jul 31, 2025

Cardinal Health 414, LLC, a PET Drug Manufacturer & Nuclear Pharmacy in Fort Lauderdale, FL, received an FDA Form 483 following an inspection conducted from July 21 to July 31, 2025. The inspection identified several critical deviations from regulatory requirements, specifically within their facilities, equipment, and quality systems. Observations included personnel disrupting "first air" in ISO aseptic processing areas, inadequate disinfection protocols for supplies moving between air quality zones, and the absence of sterile gowning in an ISO 8 room during critical preparations. Significantly, the firm failed to establish and follow written quality assurance procedures, including a repeat observation regarding inadequate good documentation practices. Deficiencies were also noted in bacterial endotoxin test (BET) suitability failure investigation procedures, where information was incomplete, and criteria were misinterpreted. The FDA highlighted a lack of effective corrective and preventive actions for recurring quality issues, such as ten instances of BET system suitability failures attributed to "operator error" without documented preventative measures. Additionally, investigations into out-of-specification drug products lacked proper documentation and accurate root cause analysis. These observations underscore the necessity for Cardinal Health 414, LLC to implement comprehensive corrective and preventive actions to ensure compliance with the Federal Food, Drug, and Cosmetic Act and Good Manufacturing Practices.