FDA 483 - Epic Laboratories LLC - April 02, 2025

Epic Laboratories LLC in Tampa, FL, was inspected and cited for multiple significant deficiencies in its manufacturing and quality control systems for OTC drug products. Key issues include inadequate microbial control for water, lack of equipment qualification and process validation, insufficient quality unit oversight, and failure to investigate out-of-specification results and stability failures. Several observations were repeat findings from a previous 2018 inspection, indicating persistent non-compliance with CGMP regulations.