Warning letterPosted April 28, 2026
FDA warning letter to Lexia LLC
CGMP/Finished Pharmaceuticals/Adulterated
FDA posted a warning letter to Lexia LLC on April 28, 2026; the letter is dated April 7, 2026. Subject: CGMP/Finished Pharmaceuticals/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Lexia LLC
- Subject
- CGMP/Finished Pharmaceuticals/Adulterated
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2026-04-07
- Posted by FDA
- 2026-04-28
- Source
- FDA warning letters ↗
CFR cited
The record cites 14 sections of 21 CFR Parts 210 and 211.
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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