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# Fresenius Kabi USA CGMP Violations
- URL: https://www.fdaweb.com/fresenius-kabi-usa-cgmp-violations/
- Published: 2026-09-29T22:02:48.000Z
- Updated: 2026-09-29T22:02:48.000Z
- Author: David McFarland
- Tags: Drugs

A 1/27-2/18 FDA inspection at the Fresenius Kabi USA drug manufacturing facility in Melrose Park, IL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/22 Warning Letter says the three specific violations were:

- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
- failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; and
- failure to establish adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug, and failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas.

FDA says the Fresenius Kabi quality systems are inadequate. The agency says that based on the nature of the identified violations and because the firm failed to correct repeat violations, the firm should engage a qualified consultant to assist it in meeting CGMP requirements.

During a 7/9 teleconference with the company, FDA says it indicated that some of the firm’s products contained particulates of biological origin, do not meet CGMPs, and are considered adulterated. As a result, the company recalled six batches of drug products on 7/16.

FDA says the company should arrange a teleconference with the agency after it submits its response to the inspection observations.

Fresenius Kabi was told to promptly address the violations and ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.