FDA 483 - Blephex, LLC - November 19, 2025

Blephex, LLC, a medical device developer/manufacturer in Brentwood, TN, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately maintain complaint files, document corrective actions, and establish essential procedures for design control, device history records, training, and quality audits. These issues indicate a broad lack of foundational quality system controls.