Lexia LLC – FDA Warning Letter, Sep 29, 2025

Lexia LLC, located in Franklin, Tennessee, received an FDA warning letter following an inspection conducted between September 23 and 29, 2025. The agency identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, which are mandated by the Federal Food, Drug, and Cosmetic Act to ensure pharmaceutical safety and quality. The investigation found that the company’s over-the-counter topical pain relief products were produced under substandard conditions, lacking the necessary controls to guarantee their identity and purity.

Main violations included a failure to perform essential laboratory testing on finished products for strength and microbial contamination before they were sold. The firm also failed to verify the identity of incoming raw materials or qualify their suppliers, often relying on unverified documentation. Furthermore, Lexia LLC lacked scientific data to support labeled expiration dates and failed to establish a quality control unit or written procedures to manage manufacturing processes and investigations.

Although Lexia LLC has notified the FDA of its intent to discontinue drug production and has deregistered its facility, the agency requires specific actions should they seek to maintain compliance or resume operations. The company must provide a comprehensive assessment of its laboratory and material systems, submit testing results for remaining product samples, and develop a scientifically sound stability program. The FDA also strongly recommends the engagement of a professional consultant to address these systemic flaws. Lexia LLC is required to respond within 15 working days and must notify the agency before resuming any future drug manufacturing activities.