CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to Lexia LLC, 2026-04-07
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated
TL;DR
FDA issued a Warning Letter to Lexia LLC on 2026-04-07 citing: CGMP/Finished Pharmaceuticals/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lexia-llc-722251-04072026
Argus analysis
Lexia LLC (MARCS-CMS 722251, FEI 3011863647) received an FDA Warning Letter dated April 7, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: CGMP/Finished Pharmaceuticals/Adulterated. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on April 28, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Lexia LLC MARCS-CMS 722251 — April 07, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mrs. Lois F. Elliott Recipient Title Co-Owner Lexia LLC 367 Riverside Drive, Suite 100 Franklin , TN 37064-8977 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-59 April 7, 2026 Dear Mrs. Elliott: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lexia LLC, FEI 3011863647, at 367 Riverside Drive, Suite 1003, Franklin, TN, from September 23 to 29, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). We have not received a response from your firm stating the actions you are taking to address the deficiencies identified during the inspection and cited on our Form FDA 483. During the inspection, your firm notified the Agency that you do not intend to manufacture drug products and have discontinued your FDA drug registration. We received your correspondence dated November 26, 2025, accepting the observations made during the inspection and reiterating your decision to discontinue production of drug products. During our inspection, our investigator observed specific violations including, but not limited to, the following. 1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)). Your firm failed to conduct adequate finished product release testing for each batch of your drug products including, but not limited to, testing the identity and strength of the active ingredient, (b)(4) , and testing for objectionable microorganisms. For example, your firm manufactures (b)(4) , an over-the-counter (OTC) topical pain relief drug product. The only tests you perform on the finished product are for viscosity, pH, and color. Your firm stated your OTC drug product lacks a final product specification and does not follow recognized standards. Appropriate testing is an essential part of ensuring that the drug products you manufacture conform to CGMP. Without adequate finished pro…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What FDA violations was Lexia LLC cited for?
- The FDA Warning Letter to Lexia LLC (issuing office: Center for Drug Evaluation and Research (CDER)) cites: CGMP/Finished Pharmaceuticals/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Lexia LLC?
- FDA issued the letter (MARCS-CMS 722251) on 2026-04-07 and posted it publicly on fda.gov on 2026-04-28.
- Is the FDA warning letter to Lexia LLC publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lexia-llc-722251-04072026.
- What does a "high" severity rating mean for this letter?
- High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to Lexia LLC, 2026-04-07. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-lexia-llc-2026-04-07-cgmp
"CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to Lexia LLC, 2026-04-07." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-lexia-llc-2026-04-07-cgmp.
Argus HQ Research. "CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to Lexia LLC, 2026-04-07." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-lexia-llc-2026-04-07-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_lexia_llc_2026_04_07_cgmp_2026,
title = {CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to Lexia LLC, 2026-04-07},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-lexia-llc-2026-04-07-cgmp},
note = {Accessed: July 13, 2026}
}