# Bio-Thera Solutions, Ltd. - Inspection Records

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

> Inspection records and compliance data for Bio-Thera Solutions, Ltd. in None, None. Access full analysis and detailed observations.

---

## Details

- Name: Bio-Thera Solutions, Ltd.
- FEI Number: 3017231337
- Country Name: China

## Related Documents

- [EMA GMP - Bio-Thera Solutions, Ltd. - 2026_NCR_MEDBIO_003 - 2026-06-12](https://www.keypedia.com/records/ema/bio-thera-solutions-ltd/61e0eba2-5df4-4d9d-a5a0-1ed9a33f3c30) — source: EMA, date: June 12, 2026
- [483 - Bio-Thera Solutions, Ltd. - 2025-09-26](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/0ed410b3-ed0f-47ef-9ece-12b7e48e19ec) — source: FDA, date: September 26, 2025
- [483 - Bio-Thera Solutions, Ltd. - 2025-09-26](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/14c342b8-6592-436e-aa7a-7d87c9f3a589) — source: FDA, date: September 26, 2025
- [483 - Bio-Thera Solutions, Ltd. - 2025-09-26](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/1291a665-3a01-4621-83d3-f5390764690e) — source: FDA, date: September 26, 2025
- [483 - Bio-Thera Solutions, Ltd. - 2025-01-17](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/9293d03a-2296-45c6-a9d9-857d59110ceb) — source: FDA, date: January 17, 2025
- [483 - Bio-Thera Solutions, Ltd. - 2025-01-17](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/ce0f7b32-d09a-452d-b874-fbdcd4b199fc) — source: FDA, date: January 17, 2025
- [483 - Bio-Thera Solutions, Ltd. - 2025-01-17](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/8b66a419-6663-4dfa-87f0-2fddfbf6cdda) — source: FDA, date: January 17, 2025
- [FDA Inspection 1276553 - Bio-Thera Solutions, Ltd. - 2025-01-17](https://www.keypedia.com/records/fda_inspections/bio-thera-solutions-ltd/80aafe90-c0c8-4026-a975-e310637008a9) — source: FDA, date: January 17, 2025
- [483 - Bio-Thera Solutions, Ltd. - 2023-08-18](https://www.keypedia.com/records/483/bio-thera-solutions-ltd/d68222ab-51cc-4390-8ca5-7d9d4f1a9c83) — source: FDA, date: August 18, 2023
- [FDA Inspection 1216356 - Bio-Thera Solutions, Ltd. - 2023-08-18](https://www.keypedia.com/records/fda_inspections/bio-thera-solutions-ltd/5db2ea8c-b698-4e90-acbd-cd90cab04871) — source: FDA, date: August 18, 2023

## Related Companies

- [Alvotech HF](https://www.keypedia.com/companies/alvotech-hf/68dcb740-c89d-4dbc-934a-d8c7ccd414ab)
- [Bavarian Nordic A/S](https://www.keypedia.com/companies/bavarian-nordic-as/c5568360-841f-40cc-a482-d0fe7d40b4e1)
- [Samsung Biologics Co., Ltd.](https://www.keypedia.com/companies/samsung-biologics-co-ltd/817b7bc4-2de1-47f4-b552-178303c8da01)
- [SciVac Ltd](https://www.keypedia.com/companies/scivac-ltd/8c2211b8-69bf-4d8f-be85-9429be552876)
- [Replimune, Inc.](https://www.keypedia.com/companies/replimune-inc/aed2f3d2-d153-4e38-af9b-19febd6fd927)
- [Hugel Inc.](https://www.keypedia.com/companies/hugel-inc/c3f52dc8-7334-454e-b30b-24a21c659c7d)
- [Shanghai Henlius Biologics Co., Ltd.](https://www.keypedia.com/companies/shanghai-henlius-biologics-co-ltd/ca560713-8df4-4bed-a460-7157ef410918)
- [Advanced Accelerator Applications USA, Inc.](https://www.keypedia.com/companies/advanced-accelerator-applications-usa-inc/ccfc70b0-8949-4d64-8e92-b725c1f0d81f)
- [Biocon Sdn. Bhd. (Company No. 201101002193)](https://www.keypedia.com/companies/biocon-sdn-bhd-company-no-201101002193/b7eb03f4-676c-44c0-af88-528fbc4236a8)
- [Lonza Houston, Inc](https://www.keypedia.com/companies/lonza-houston-inc/c3ae4db9-9aba-4b65-9e2b-06e1632112a6)

## Related Officers

- [Zhong Zhao](https://www.keypedia.com/people/zhong-zhao/a8543d5d-c319-4e2f-a2e7-b9d25a94a405)
- [Andrea George](https://www.keypedia.com/people/andrea-george/8e21cd66-64da-49f7-ba5e-4a9b9e103e96)
- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)
- [other](https://www.keypedia.com/people/jeanne-m-fringer/4d970694-416e-42d6-9ec3-7bf3e337fb9a)
- [Jiangsong Jiang, Ph.D. Pharmaceutical Scientist](https://www.keypedia.com/people/jiangsong-jiang-phd-pharmaceutical-scientist/6db9648a-e851-47a6-a7a1-066f7710426d)
- [Nozomi Sakakibara, Ph.D. Senior Research Scientist](https://www.keypedia.com/people/nozomi-sakakibara-phd-senior-research-scientist/fd3ec0a2-f3a9-4c36-a67e-cecdfb7cd988)
