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

During an inspection conducted from January 30, 2023, to March 6, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Fresenius Kabi Compounding, LLC, an outsourcing facility in Canton, MA. The inspection revealed two significant observations indicating potential non-compliance with regulations under the Federal Food, Drug and Cosmetic Act, particularly concerning sterile drug manufacturing.

The primary observation noted that the company's procedures designed to prevent microbiological contamination of sterile drug products were not adequately established, written, or followed. Investigators observed production operators leaning into ISO 5 laminar flow hoods during cleaning, immediately before manufacturing sterile medications such as Rocuronium, Phenylephrine HCl, Vancomycin HCl, and Norepinephrine. This practice obstructed the unidirectional airflow, compromising the sterile environment.

A second critical observation highlighted that the accuracy, sensitivity, specificity, and reproducibility of test methods had not been properly established. Specifically, the USP <71> method suitability tests for injectable Vancomycin products failed to adequately recover Bacillus subtilis. This failure suggests that the antibiotic was not sufficiently neutralized during testing, potentially leading to undetected microbial contamination in numerous batches of injectable Vancomycin distributed to patients between June 2021 and January 2023.

The issuance of an FDA 483 requires Fresenius Kabi Compounding, LLC, to provide a formal written response outlining corrective actions taken or planned to address these deficiencies and ensure compliance with good manufacturing practices.