FDA EIR - Fresenius Kabi USA, LLC - November 20, 2012

An FDA inspection of Fresenius Kabi USA, LLC's Melrose Park, IL facility took place from November 13-20, 2012, governed by Compliance Programs 7356.002 and 7371.001. Key issues identified included the facility's failure to register with the FDA despite engaging in contract laboratory testing for quality control and stability sample storage. Significant concerns were also raised regarding the firm's laboratory control systems. Specifically, system suitability practices for analytical tests were deemed insufficient, lacking consistent documentation of failure causes, justification for maintaining system control, and comprehensive Quality Assurance (QA) review of these failures. Additionally, deficiencies were noted in environmental monitoring, as temperature and humidity logbooks did not clearly indicate whether alert-level notifications were high or low. There was also an absence of documented QA review for trending these alerts to proactively prevent excursions. Fresenius Kabi committed to registering the facility, implementing a new standard operating procedure requiring documentation of all system suitability failures for QA review, conducting a retrospective review of past failures, and evaluating alert-level notification trends for preventative maintenance. While no formal FDA-483 was issued, these critical concerns were thoroughly discussed with facility management.