FDA 483 - PReye, LLC - March 19, 2026

FREYE LLC, a repackager/relabeler of sterile drug products in Wheat Ridge, CO, was cited for significant deficiencies during an FDA inspection. Observations included inadequate aseptic processing environments, distribution of an OTC sterile drug product with unpermitted active ingredients, failure to perform identity testing on components, and a complete lack of an effective quality control unit. These conditions indicate a high risk of contamination and non-conforming products.