FDA 483 - LICO Industries, LLC - February 19, 2026

LICO Industries, LLC, a repackager and relabeler of OTC drug products in Mohave Valley, AZ, was cited for significant deficiencies during an FDA inspection. The inspection revealed a lack of an adequate quality control unit, failure to test incoming components for identity, and inadequate production and process controls, including issues with process and cleaning validation. These repeat observations indicate serious and systemic quality control failures.