# FDA 483 - Baxter Healthcare SA - December 13, 2024

Source: https://www.globalkeysolutions.net/records/483/baxter-healthcare-sa/375ca287-ee65-4b58-bd8b-69db4c9328fb

> FDA 483 for Baxter Healthcare SA on December 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare SA
- Inspection Date: 2024-12-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Baxter Healthcare SA in Singapore revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate unexplained discrepancies, product complaints, and out-of-specification results. Additionally, inadequate laboratory controls for environmental monitoring and microbial identification, along with a failure to follow written procedures for component storage and handling, were observed.

## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)
- [David J. Gomes](https://www.globalkeysolutions.net/people/david-j-gomes/dc3d1557-3bbc-4ed6-85fc-84b3462715c1)

Company: https://www.globalkeysolutions.net/companies/baxter-healthcare-sa/6ea26d01-0f67-483b-ba98-e813f35a2a60

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