Warning letterPosted December 9, 2025
FDA warning letter to BioXtek LLC
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
FDA posted a warning letter to BioXtek LLC on December 9, 2025; the letter is dated December 1, 2025. Subject: Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA). Issuing office: Office of Compliance and Biologics Quality.
On the record
- Company
- BioXtek LLC
- Subject
- Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
- Issuing office
- Office of Compliance and Biologics Quality
- Letter dated
- 2025-12-01
- Posted by FDA
- 2025-12-09
- Source
- FDA warning letters ↗
CFR cited
The record cites 4 sections of 21 CFR Part 1271.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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