CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to Lexia LLC, April 7, 2026

FDA Warning Letter — Violations FDA cited at Lexia LLC

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 product release testing, you do not have scientific evidence that each batch of drug product conforms to predetermined specifications before release. In response to this letter, provide: A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision. o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter. o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls. A comprehensive assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and