# FDA 483 - Fresenius Kabi USA, LLC - September 07, 2023

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/7b404bb8-ddff-4ee7-8a5a-f2bb4586134d

> FDA 483 for Fresenius Kabi USA, LLC on September 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA, LLC
- Inspection Date: 2023-09-07
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Fresenius Kabi USA, LLC in North Andover, MA, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed inadequate procedures for corrective and preventive actions, design changes, and risk analysis, leading to product issues and recalls. Additionally, the firm failed to report a device correction to the FDA and did not submit required Medical Device Reports (MDRs) for malfunctions that resulted in a Class I recall.

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## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/fresenius-kabi-usa-llc/f0976e16-40e3-475b-8dc0-c9e721658b4a

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94