Warning letterPosted December 18, 2025
FDA warning letter to ShapeShifter Apparel, LLC
Failure to Register and List/Misbranded
FDA posted a warning letter to ShapeShifter Apparel, LLC on December 18, 2025; the letter is dated December 16, 2025. Subject: Failure to Register and List/Misbranded. Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- ShapeShifter Apparel, LLC
- Subject
- Failure to Register and List/Misbranded
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2025-12-16
- Posted by FDA
- 2025-12-18
- Source
- FDA warning letters ↗
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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