# FDA 483 - Baxter Healthcare Corporation - August 18, 2023

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/448b5015-bafe-4bcc-990e-1b4b6fb19bdf

> FDA 483 for Baxter Healthcare Corporation on August 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2023-08-18
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Baxter Healthcare Corporation in Round Lake, IL, identified that procedures for design validation were not adequately established. Specifically, a claim regarding the Novum IQ Syringe Pump's Smart Battery Pack degradation was not validated using production-equivalent units. This indicates a deficiency in ensuring product claims are thoroughly tested according to established procedures.

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## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)
- [Kyran R Gibson](https://www.keypedia.com/people/kyran-r-gibson/640f53df-0c2f-4027-bfcb-9010c2b1639e)

Company: https://www.keypedia.com/companies/baxter-healthcare-corporation/3a2bb12d-f7e5-4c09-9678-b4bec58553a9

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