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

Source: https://www.keypedia.com/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.

---

## 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)
- Summary: Bio-Thera Solutions, Ltd. in Huangpu District, Guangzhou City, China, was inspected regarding its manufacturing operations. The inspection revealed deficiencies in environmental monitoring for its RABS vial filling line and inadequate procedures for facility microbial control, specifically concerning sink drain sanitization in production suites. These issues indicate potential risks to product quality and sterility.

## Related Documents

- [483 - 2025-01-17](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/ce0f7b32-d09a-452d-b874-fbdcd4b199fc)
- [483 - 2025-01-17](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/8b66a419-6663-4dfa-87f0-2fddfbf6cdda)
- [483 - 2025-09-26](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/14c342b8-6592-436e-aa7a-7d87c9f3a589)
- [483 - 2025-09-26](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/1291a665-3a01-4621-83d3-f5390764690e)

## Related Officers

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

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