FDA 483 - Fresenius Kabi Compounding, LLC - October 09, 2025

Fresenius Kabi Compounding, LLC, an outsourcing facility located in Canton, MA, underwent an FDA inspection from October 9, 2025, to November 5, 2025. The inspection resulted in an FDA Form 483, highlighting critical issues in quality control and sterile manufacturing. A primary observation detailed the company"s inadequate review and investigation of unexplained discrepancies, specifically concerning defects in IV bag container closures for compounded sterile drug products like Vancomycin HCl and Phenylephrine HCl. Investigations were found deficient in assessing the full scope of affected lots, inspecting retains, notifying customers, and implementing preventative actions for recurring issues, including manufacturing defects in supplied bags and storage-related pressure damage, despite a high volume of customer complaints. Further, the FDA observed failures in procedures designed to prevent microbiological contamination of sterile drug products. These included instances of operators obstructing first-pass air in laminar flow hoods, performing rapid movements in ISO environments, and leaning into sterile areas, all potentially compromising product sterility. The firm also conducted reconstitution and pooling of vancomycin solutions outside validated ISO hoods without demonstrating sterility assurance. Additionally, there was an absence of environmental monitoring on personnel contact surfaces of scales and pumps, a lack of regular sporicidal treatment for equipment stored outside ISO areas, and no requirement for operators to sanitize gloves after touching such equipment. Fresenius Kabi Compounding, LLC must respond to these observations by developing and implementing robust corrective and preventative actions to ensure product quality and patient safety.