# FDA 483 - Baxter Healthcare Corporation - February 09, 2024

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/17d95756-c80b-494c-958b-dbcc9e7dbc61

> FDA 483 for Baxter Healthcare Corporation on February 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2024-02-09
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Baxter Healthcare Corporation, a sterile drug manufacturer in Marion, NC, received a Form 483 with seven observations, including repeat findings. The inspection revealed significant deficiencies in production and process controls, particularly concerning particulate matter prevention and visual inspection programs. Additionally, issues were noted in laboratory controls, water for injection systems, complaint handling, and equipment maintenance, indicating a systemic lack of robust quality oversight.

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## Related Officers

- [Fabia M Lugo](https://www.keypedia.com/people/fabia-m-lugo/336ff45f-5188-42f6-91cd-3b60931c0602)
- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)
- [Microbiologist](https://www.keypedia.com/people/susan-t-hadman/512c3274-4da8-4f5a-a081-965ab5ec84e6)
- [Investigator](https://www.keypedia.com/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.keypedia.com/companies/baxter-healthcare-corporation/19a30564-2115-4586-a055-e1b5efcf06ee

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7