Neobiosis LLC – FDA 483, Feb 21, 2023

Neobiosis LLC, a manufacturer in Gainesville, FL, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies in aseptic processing validation, environmental monitoring, production controls, stability testing, container closure systems, and reserve sample retention. These issues indicate a lack of adequate controls to ensure the sterility, quality, and purity of their drug products.