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# Fresenius Kabi Facility Hit With FDA-483
- URL: https://www.fdaweb.com/fresenius-kabi-facility-hit-with-fda-483/
- Published: 2023-07-14T12:00:00.000Z
- Updated: 2026-09-14T18:44:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154877

A 3/6-completed FDA inspection of Fresenius Kabi’s Canton, MA outsourcing facility resulted in a two-item [Form FDA-483](https://www.fda.gov/media/170140/download?ref=fdaweb.com) that cited the firm over GMP deviations. For example, the facility’s procedures to prevent microbiological contamination of drug products purporting to be sterile are not established, written, or followed, according to the just-posted inspection form. Specifically, it says production operators were observed performing preproduction cleaning of certain equipment, but multiple operators were leaning their bodies against the equipment. Additionally, the FDA-483 said the accuracy, sensitivity, specificity, and reproducibility of test methods had not been established.