# FDA 483 - Fresenius Kabi USA, LLC - March 18, 2022

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/da88c2a6-21ad-4e91-b59b-3a90a48177bf

> FDA 483 for Fresenius Kabi USA, LLC on March 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA, LLC
- Inspection Date: 2022-03-18
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Ivenix, Inc. in North Andover, MA, identified a significant issue related to design verification. The firm failed to confirm that design output meets design input requirements, specifically regarding the pressure resistance of administration set drip chambers. This indicates a moderate severity finding concerning product design and testing.

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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