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

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/64a74ef2-b9e5-4d57-8a10-6cd2a8cea2a6

> 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: San Juan District Office
- Summary: An FDA inspection of Baxter Healthcare Corporation's drug manufacturing facility in Aibonito, Puerto Rico, on November 29, 2023, identified a significant observation regarding the firm's quality system. The primary issue noted was that complaint records are deficient, specifically failing to include comprehensive investigation findings and effective follow-up actions. The observation detailed a persistent problem with customer complaints concerning solution product bag leaks. Over the last three years, the company has received multiple complaints for this defect, with a substantial portion occurring in 2023, some of which remained unresolved at the time of inspection and affected numerous product units. The FDA noted that actions previously implemented to correct the deficiency have not resolved the issue, as complaints for the same defect continue to be received. This inspectional observation, issued under the regulatory framework of Section 704(b) of the Federal Food, Drug and Cosmetic Act, indicates that Baxter Healthcare Corporation must thoroughly address these identified shortcomings. The required action for the firm is to enhance its complaint investigation processes and implement effective, sustainable solutions to prevent recurring product bag leaks and ensure compliance with regulatory standards.

## Related Documents

- [483 - 2023-11-29](https://www.keypedia.com/records/483/baxter-healthcare-corporation/38df54a1-bc41-4f96-ab3a-d32350307e6b)

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Company: https://www.keypedia.com/companies/baxter-healthcare-corporation/37ed59ef-c570-47ec-8477-ca9c766cac29

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8