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

Source: https://www.keypedia.com/records/483/bio-thera-solutions-ltd/1291a665-3a01-4621-83d3-f5390764690e

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Bio-Thera Solutions, Ltd. in Guangzhou, China, revealed significant deficiencies in their drug substance and drug product manufacturing operations. The firm failed to establish and follow adequate procedures for production controls, media fill validation, and visible particle prevention. Additionally, the Quality Unit's responsibilities were found to be inadequate, and the firm demonstrated a failure to thoroughly investigate discrepancies and ensure proper laboratory instrument qualification.

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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/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd