# FDA 483 - Bio-Thera Solutions, Ltd. - January 17, 2025

Source: https://www.globalkeysolutions.net/records/483/bio-thera-solutions-ltd/8b66a419-6663-4dfa-87f0-2fddfbf6cdda

> FDA 483 for Bio-Thera Solutions, Ltd. on January 17, 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: 2025-01-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Bio-Thera Solutions, Ltd. in Huangpu District, Guangzhou, revealed significant deficiencies in their drug substance and drug product manufacturing operations. The firm failed to establish and follow adequate procedures for preventing microbiological contamination, ensuring product quality through proper visual inspection and sampling, and maintaining data integrity. Furthermore, the Quality Unit's responsibilities and laboratory controls were found to be inadequate, raising concerns about the sterility and overall quality of their sterile drug products.

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## Related Officers

- [Jiangsong Jiang](https://www.globalkeysolutions.net/people/jiangsong-jiang/055e81c4-48a9-423d-b90f-ea0d08df79e1)
- [Yiwei Li, Ph.D., Supervisory Chemist](https://www.globalkeysolutions.net/people/yiwei-li-phd-supervisory-chemist/25391f15-b3ee-400e-9e10-4fc2b674facc)
- [other](https://www.globalkeysolutions.net/people/jeanne-m-fringer/4d970694-416e-42d6-9ec3-7bf3e337fb9a)
- [Jiangsong Jiang, Ph.D. Pharmaceutical Scientist](https://www.globalkeysolutions.net/people/jiangsong-jiang-phd-pharmaceutical-scientist/6db9648a-e851-47a6-a7a1-066f7710426d)
- [James Frisby, Ph.D., Chemist](https://www.globalkeysolutions.net/people/james-frisby-phd-chemist/9be43edf-b16e-45f4-a1d1-0ddda3986fe0)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8