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Bio-Thera Solutions, Ltd., China – FDA Inspections

Inspection records and compliance data for Bio-Thera Solutions, Ltd.. 2 FDA inspections on record, 2 Form 483s, last inspected January 17, 2025.

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Company Profile

This profile covers Bio-Thera Solutions, Ltd. based in China.

FDA Inspection History

FDA inspections
2
OAI
0
VAI
0
NAI
0
Unclassified
2
Form 483s
2
Warning letters
0

First inspected August 18, 2023. Last inspected January 17, 2025.

FDA inspections (2)

DateResultFDA center(s)Insp. #
January 17, 2025Not classifiedHuman Drugs1276553
August 18, 2023Not classifiedHuman Drugs1216356
FDA documents

Form 483s (5)

  • Form 483s · September 26, 2025
  • Form 483s · January 17, 2025
  • Form 483s · February 8, 2024
  • Form 483s · August 18, 2023
  • Form 483s · October 6, 2017
Other regulators (1)
  • EMA · 1 inspection · last June 12, 2026
People (6)
Jie He
Person
Rose Xu
Person
Zhong Zhao
Person
Andrea George
Person
Yiwei Li
Person
Jeanne Fringer
Person
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Company Information

Name

Bio-Thera Solutions, Ltd.

FEI Number

3017231337

Address

China

Country

China

ID: a06cd8e7-9627-48bf-9f70-d2458bdc560b

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