# FDA 483 - Bio-Thera Solutions, Ltd. - August 18, 2023

Source: https://www.globalkeysolutions.net/records/483/bio-thera-solutions-ltd/d68222ab-51cc-4390-8ca5-7d9d4f1a9c83

> FDA 483 for Bio-Thera Solutions, Ltd. on August 18, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Thera Solutions, Ltd.
- Inspection Date: 2023-08-18
- Product Type: biologics
- 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)
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- [483 - 2025-09-26](https://www.globalkeysolutions.net/records/483/bio-thera-solutions-ltd/1291a665-3a01-4621-83d3-f5390764690e)

## Related Officers

- [Andrea George](https://www.globalkeysolutions.net/people/andrea-george/8e21cd66-64da-49f7-ba5e-4a9b9e103e96)
- [Zhong Zhao](https://www.globalkeysolutions.net/people/zhong-zhao/a8543d5d-c319-4e2f-a2e7-b9d25a94a405)
- [Investigator](https://www.globalkeysolutions.net/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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