# FDA 483 - Baxter Healthcare Corporation - March 26, 2025

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/e2b8895c-150c-49dc-a10b-00bb1bd891f5

> FDA 483 for Baxter Healthcare Corporation on March 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2025-03-26
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: Baxter Healthcare Corporation in Guayama, PR, received a Form 483 following an inspection from March 24-26, 2025, for its drug manufacturing facility. The inspection revealed significant issues with the firm's quality control unit, specifically regarding the securing and storage of quality and production records. Investigators found original records, batch records, and unapproved documents discarded in trash cans and shredding bags, indicating a failure to maintain data integrity and follow established procedures for documentation and record management.

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)
- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [Christian F. Gomez Lugo](https://www.keypedia.com/people/christian-f-gomez-lugo/866e531a-6354-45b2-8e43-1dfc9d146caf)

Company: https://www.keypedia.com/companies/baxter-healthcare-corporation/511e2b34-f9c9-4059-b74d-d1cd59ed6678

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