# FDA 483 - Baxter Healthcare (Guangzhou) Co., Ltd. - December 13, 2024

Source: https://www.keypedia.com/records/483/baxter-healthcare-guangzhou-co-ltd/c22ba2a6-ed5b-43f3-a2ec-eed7ca3d3e7e

> FDA 483 for Baxter Healthcare (Guangzhou) Co., Ltd. on December 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare (Guangzhou) Co., Ltd.
- Inspection Date: 2024-12-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Baxter Healthcare (Guangzhou) Co., Ltd. revealed critical deficiencies in quality control and aseptic manufacturing processes. The firm failed to reject defective components, lacked adequate controls to prevent microbiological contamination of sterile drug products, and exhibited poor data integrity practices. These issues led to the shipment of potentially compromised sterile drugs to the U.S. market.

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)
- [investigator](https://www.keypedia.com/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)

Company: https://www.keypedia.com/companies/baxter-healthcare-guangzhou-co-ltd/a412bbf3-7933-460e-8f24-df6fc5b0e600

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