# FDA 483 - Baxter Healthcare Corporation - December 21, 2018

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/22205250-20b0-4d22-a0f6-563a95762541

> FDA 483 for Baxter Healthcare Corporation on December 21, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2018-12-21
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Baxter Healthcare Corporation received 12 observations related to significant deficiencies in its quality control unit, laboratory operations, and manufacturing processes. Key issues include inadequate complaint evaluation, failure to thoroughly investigate discrepancies and OOS results, lack of proper stability program implementation, and deficiencies in visual inspection certification and supplier management. The firm also failed to maintain facilities and equipment, ensure complete laboratory records for instrument calibration, and establish accurate and reliable test methods, indicating a systemic breakdown in quality assurance and control.

## Related Documents

- [483 - 2024-07-19](https://www.keypedia.com/records/483/baxter-healthcare-corporation/354827b8-1c77-492e-af58-0025cbb0d027)

## Related Officers

- [Miguel A. Martinez](https://www.keypedia.com/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Laurimer Kuilan-Torres](https://www.keypedia.com/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)

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-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6