# FDA 483 - Baxter Healthcare Corporation - November 29, 2023

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/38df54a1-bc41-4f96-ab3a-d32350307e6b

> FDA 483 for Baxter Healthcare Corporation on November 29, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2023-11-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Baxter Healthcare Corporation in Aibonito, PR, revealed a significant deficiency in their complaint handling system. The firm failed to adequately investigate and resolve multiple customer complaints regarding solution product bag leaks, with many complaints remaining open and unresolved over several years. This indicates a persistent quality system issue that has not been effectively addressed.

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- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
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Company: https://www.keypedia.com/companies/baxter-healthcare-corporation/37ed59ef-c570-47ec-8477-ca9c766cac29

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6