Blephex, LLC – FDA Warning Letter, Nov 19, 2025

BlephEx, LLC, located in Brentwood, Tennessee, received an FDA warning letter following an inspection conducted from October 30 to November 19, 2025. The agency identified significant violations involving three medical devices: the BlephEx Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps. The primary regulatory issue is that the company marketed these devices for medical treatments—such as managing blepharitis, dry eye disease, and pre-surgical preparation—that exceed their original legal classifications for basic hygiene or general surgical assistance. By promoting these therapeutic uses without obtaining required FDA clearances or approvals, the products are considered unapproved and misbranded under the Federal Food, Drug, and Cosmetic Act. Additionally, the inspection revealed systemic failures in the company’s quality management. BlephEx failed to report serious safety incidents involving devices that smoked or caught fire. The firm also neglected to investigate more than 177 customer complaints, lacked a formal process for corrective actions, and failed to maintain proper manufacturing records or perform internal quality audits. BlephEx must immediately cease marketing the devices for unapproved uses and submit a detailed corrective action plan within 15 business days. This response must document how the firm will resolve its quality system deficiencies and ensure future compliance with current medical device regulations.