Warning letterPosted January 20, 2026
FDA warning letter to Genetrace
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
FDA posted a warning letter to Genetrace on January 20, 2026; the letter is dated January 8, 2026. Subject: Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Issuing office: Center for Biologics Evaluation and Research (CBER).
On the record
- Company
- Genetrace
- Subject
- Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
- Issuing office
- Center for Biologics Evaluation and Research (CBER)
- Letter dated
- 2026-01-08
- Posted by FDA
- 2026-01-20
- Source
- FDA warning letters ↗
The full record
An account shows the violations FDA described and each CFR section it cited.
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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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