Warning letterPosted September 2, 2025
FDA warning letter to Trew Balance
Unapproved New Drugs/Ophthalmic Drug Products
FDA posted a warning letter to Trew Balance on September 2, 2025; the letter is dated August 25, 2025. Subject: Unapproved New Drugs/Ophthalmic Drug Products. Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Trew Balance
- Subject
- Unapproved New Drugs/Ophthalmic Drug Products
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2025-08-25
- Posted by FDA
- 2025-09-02
- 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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