Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3017231337.
Observations13
Issue DateJanuary 17, 2025
StatusNo Warning Letter
Establishment TypeDrug Substance Manufacturer
Related Inspections0
Establishment Details
Firm
Bio-Thera Solutions, Ltd.
Location
China
FEI Number
3017231337
Establishment Type
Drug Substance Manufacturer
Issue Date
January 17, 2025
Country
China
Inspection History
We hold no FDA inspection matched to this establishment.
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