FDA 483 - Osmosis, LLC - January 13, 2023

An FDA inspection of Osmozis, LLC, a dietary supplement manufacturer in Evergreen, CO, from January 5-13, 2023, revealed numerous significant deficiencies across its operations. The firm failed to establish and follow written procedures for critical areas including quality control, component and finished product specifications, supplier qualification, sanitation, complaint handling, master manufacturing records, batch production records, and handling of returned products. These widespread issues indicate a severe lack of control over manufacturing processes and product quality.