FDA 483 - Fresenius Kabi Compounding, LLC - March 06, 2023

Fresenius Kabi Compounding, LLC in Canton, MA, was cited with two observations during an FDA inspection of its outsourcing facility. The firm failed to follow procedures designed to prevent microbiological contamination of sterile drug products, as operators were observed blocking unidirectional airflow in ISO 5 HLFs. Additionally, the accuracy and suitability of test methods for injectable Vancomycin were not established, as USP <71> sterility tests failed to recover a challenge organism, indicating significant concerns regarding sterility assurance and quality control.