FDA EIR - Fresenius Kabi USA, LLC - August 12, 2019

An FDA inspection of Fresenius Kabi USA, LLC, a sterile drug manufacturer in Grand Island, NY, was conducted from July 11-19, 2013. This surveillance inspection, part of the CDER FY'13 cGMP work plan, aimed to ensure compliance with Current Good Manufacturing Practices for sterile drug processes. The inspection also included pre-approval coverage for Heparin Sodium Injection and Doxycycline for Injection, and reviewed recent field alerts. During the inspection, the FDA issued a Form 483 outlining two main observations. First, the company lacked established control procedures to evaluate how manufacturing processes might introduce variability into in-process materials and drug products, specifically regarding the effects of decontamination on products made on Lines 2, 4, and 5. Second, the responsibilities and operational procedures for the quality control unit were not fully implemented or followed. Previously, a 2011 FDA inspection was classified as Voluntary Action Indicated (VAI), citing deficiencies such as undocumented deviations in batch records, inadequate documentation of discrepancies, failure to follow written process controls, and untimely submission of field alert reports. For the current inspection, Fresenius Kabi management acknowledged the observations and committed to submitting a written response within 15 business days.