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

Source: https://www.globalkeysolutions.net/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)

## Related Documents

- [483 - 2025-01-17](https://www.globalkeysolutions.net/records/483/bio-thera-solutions-ltd/8b66a419-6663-4dfa-87f0-2fddfbf6cdda)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/bio-thera-solutions-ltd/1242ec8b-aa9d-4588-828c-dbb25977a455)
- [483 - 2023-08-18](https://www.globalkeysolutions.net/records/483/bio-thera-solutions-ltd/d68222ab-51cc-4390-8ca5-7d9d4f1a9c83)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/bio-thera-solutions-ltd/e49c1174-2d4e-46d7-bfe6-e637c8758225)
- [483 - 2025-01-17](https://www.globalkeysolutions.net/records/483/bio-thera-solutions-ltd/53816ff0-d1b6-44cf-a3f6-00c3986b1d86)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd