# FDA 483 - Fresenius Kabi USA LLC - May 18, 2020

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/d336177f-cc20-4bc6-a876-9138e3d07f5a

> FDA 483 for Fresenius Kabi USA LLC on May 18, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA LLC
- Inspection Date: 2020-05-18
- Product Type: Drugs
- Office Name: Chicago District Office
- Summary: This FDA Form 483 document outlines several significant observations made during an inspection, indicating deficiencies in the facility's quality control, manufacturing, and record-keeping practices.

**Key Observations:**

1.  **Quality Control Unit Deficiencies:** The responsibilities and procedures for the quality control unit are not documented in writing and are not fully adhered to. This suggests a lack of formalization and consistent execution within the quality system.

2.  **Equipment Cleaning and Maintenance:** Written procedures for the cleaning and maintenance of equipment and utensils used in the manufacture, processing, packing, or holding of drug products are not established or followed. This poses a risk of contamination and impacts product quality.

3.  **Sterility Assurance:** Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, or followed. This is a critical finding, directly impacting the safety and efficacy of sterile products.

4.  **Batch Production Records:** Batch production and control records are deficient as they do not include documentation of the accomplishment of each significant step in manufacturing, processing, and packing. This indicates a lack of thoroughness in record-keeping, hindering traceability and accountability.

5.  **Discrepancy Investigations:** There is a failure to thoroughly review unexplained discrepancies and the failure of a batch or its components to meet specifications, regardless of whether the batch has been distributed. This highlights a critical gap in the quality system's ability to identify and address non

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## Related Officers

- [Brian D. Nicholson](https://www.keypedia.com/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.keypedia.com/companies/fresenius-kabi-usa-llc/f694c817-29ea-47cf-b819-8cf11fbfc4da

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669