# FDA 483 - Baxter Corporation - January 31, 2025

Source: https://www.keypedia.com/records/483/baxter-corporation/8961015e-1405-44a8-86c9-d493cffcdf40

> FDA 483 for Baxter Corporation on January 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Corporation
- Inspection Date: 2025-01-31
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Baxter Corporation, a parenteral drug manufacturer in Alliston, was cited for significant deficiencies during an FDA inspection. Observations included inadequate investigations into unexplained discrepancies and packaging failures, issues with manufacturing process validation and container integrity, and failures in preventing contamination and conducting proper component identification testing. These issues indicate a lack of robust quality control and investigation practices.

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Company: https://www.keypedia.com/companies/baxter-corporation/ca56a675-623d-4cdd-9810-05ae4ba274e0

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8