# FDA 483 - Bio-Thera Solutions, Ltd. - September 26, 2025

Source: https://www.keypedia.com/records/483/bio-thera-solutions-ltd/0ed410b3-ed0f-47ef-9ece-12b7e48e19ec

> FDA 483 for Bio-Thera Solutions, Ltd. on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Thera Solutions, Ltd.
- Inspection Date: 2025-09-26
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Bio-Thera Solutions, Ltd. in Guangzhou, China, was cited for significant deficiencies across its drug substance and drug product manufacturing operations. The inspection revealed widespread issues including inadequate process controls, poor quality unit oversight, insufficient investigations into batch failures and visible particles, and unqualified laboratory methods and instruments. These findings indicate a lack of assurance in product quality and consistency.

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## Related Officers

- [Jie He](https://www.keypedia.com/people/jie-he/162aef4b-4b22-48e5-9a50-9b2e9684d589)
- [Rose Xu](https://www.keypedia.com/people/rose-xu/60ba3a00-9457-4396-aa6d-ffa374fdb7ae)
- [Yun Wu](https://www.keypedia.com/people/yun-wu/ae378596-ea82-4254-b169-b592878202eb)
- [Christina Farris](https://www.keypedia.com/people/christina-farris/cf4c3a4d-bf6e-424a-9e7d-f5dd32e41769)

Company: https://www.keypedia.com/companies/bio-thera-solutions-ltd/a06cd8e7-9627-48bf-9f70-d2458bdc560b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4