FDA 483 - Vitti Labs, LLC - December 20, 2021

Vitti Labs, LLC in Liberty, MO, was inspected by the FDA from December 6-20, 2021, as a biological drug manufacturer. The inspection revealed significant deficiencies in aseptic processing validation, production and process controls, laboratory records, and environmental controls for its injectable, ophthalmic, and topical products derived from human umbilical cord and amniotic membrane. These issues indicate a lack of adequate procedures to ensure product sterility, quality, and purity.