Lucin Organics, LLC – FDA 483, Jul 15, 2026

LUCIN ORGANICS LLC in Broomfield, CO, received a Form 483 with six observations indicating severe deficiencies across its quality system, production, laboratory controls, and facilities. The firm lacks fundamental quality unit oversight, essential documentation like batch records and CAPA, process and cleaning validations, and adequate laboratory testing and stability programs for its OTC drug products. These issues represent a systemic failure to operate under current Good Manufacturing Practices (CGMP).