> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Hits Fresenius with 6-item Form-483
- URL: https://www.fdaweb.com/fda-hits-fresenius-with-6-item-form-483/
- Published: 2021-02-01T12:00:00.000Z
- Updated: 2026-09-14T16:44:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148565

Fresenius Kabi was issued a six-item [FDA Form-483](https://www.fda.gov/media/145539/download?ref=fdaweb.com) after an inspection in May 2020 documented GMP deficiencies at its Melrose Park, IL manufacturing facility. For example, Fresenius’ responsibilities and procedures applicable to the quality control unit were not in writing and fully followed, the inspection form said. The agency also cited the firm’s written procedures that were not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of drug products. Additionally, FDA said procedures designed to prevent microbiological contamination of drug products purporting to be sterile were not established, written and followed.