# FDA 483 - Baxter Healthcare Corporation - August 01, 2024

Source: https://www.globalkeysolutions.net/records/483/baxter-healthcare-corporation/02bbb3b0-c243-4877-9c00-8ffe4e0cac64

> FDA 483 for Baxter Healthcare Corporation on August 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2024-08-01
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: The FDA inspection of Baxter Healthcare Corporation in Round Lake, IL, identified five significant issues related to drug manufacturing. These included inadequate facility separation for cephalosporin and non-cephalosporin production, a deficient visual inspection program for finished products, and a failure to thoroughly investigate discrepancies and consumer complaints. Additionally, the firm's visual inspection training was found to be inadequate, and equipment cleaning practices were insufficient, leading to potential contamination risks.

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.globalkeysolutions.net/records/warning_letter/baxter-healthcare-corporation/30f31ddb-6208-422d-b9c4-eae287cef146)
- [WARNING_LETTER - 2013-04-19](https://www.globalkeysolutions.net/records/warning_letter/baxter-healthcare-corporation/2c84645f-670e-4602-a16f-b56744173190)
- [WARNING_LETTER - Unknown Date](https://www.globalkeysolutions.net/records/warning_letter/baxter-healthcare-corporation/38c366e8-7c89-43c3-9ec2-0991b551bef7)
- [483 - 2023-08-18](https://www.globalkeysolutions.net/records/483/baxter-healthcare-corporation/448b5015-bafe-4bcc-990e-1b4b6fb19bdf)

## Related Officers

- [Monica E. Murie](https://www.globalkeysolutions.net/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)
- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

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

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