# FDA 483 - Baxter Healthcare Corporation - July 19, 2024

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/354827b8-1c77-492e-af58-0025cbb0d027

> FDA 483 for Baxter Healthcare Corporation on July 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2024-07-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Baxter Healthcare Corporation, a sterile drug manufacturer in Jayuya, PR, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to adequately investigate Out of Specification results and laboratory errors, maintain contemporaneous documentation, and ensure proper equipment cleaning and maintenance. These issues collectively compromise product quality, data integrity, and the sterility assurance of drug products.

## Related Documents

- [483 - 2018-12-21](https://www.keypedia.com/records/483/baxter-healthcare-corporation/22205250-20b0-4d22-a0f6-563a95762541)

## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [investigator](https://www.keypedia.com/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)

Company: https://www.keypedia.com/companies/baxter-healthcare-corporation/0296844d-4369-423c-824a-f7d71344ec07

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab