FDA EIR - Fresenius Kabi USA, LLC - February 05, 2019

A domestic FDA inspection of Fresenius Kabi USA, LLC's sterile finished drug manufacturing facility in Wilson, NC, was conducted from January 28 to February 5, 2019. The inspection, carried out under established FDA compliance programs for sterile drug processes, identified two significant observations related to manufacturing quality and control.

Firstly, the company was cited for deficiencies in its system for cleaning and disinfecting equipment in aseptic processing areas. Specifically, a validated cleaning procedure for aseptic compounding and filling equipment was not implemented until 2018. Furthermore, the 2018 validation, performed for Morphine Sulfate, failed to utilize the identified "worst-case" product, Ondansetron, which is critical for ensuring robust cleaning validation.

Secondly, the inspection noted that the responsibilities and procedures of the quality control unit were not fully followed. The Quality Assurance department, a core component of the quality control unit, was not involved in reviewing executed clean-to-release forms or making final release judgments for quarantined aseptic manufacturing equipment. Instead, this critical decision-making authority rested with the Tech Transfer department, which operates outside the formal quality unit structure.

Fresenius Kabi management was issued an FDA Form 483, detailing these observations, and committed to providing a written response within 15 business days. The company has initiated corrective actions, including a plan to complete the comprehensive cleaning validation for Ondansetron by July 2019 and revising internal procedures to ensure the Quality Assurance department's appropriate involvement in equipment release.