FDA 483 - ImmuCell Corporation - March 29, 2022

ImmuCell Corporation in Portland, ME, an Active Pharmaceutical Ingredient Manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate qualification of manufacturing rooms and equipment, a systemic failure of the Quality Unit to document and investigate deviations, and a lack of proper supplier qualification for critical materials. These issues indicate a broad lack of control over manufacturing processes and quality assurance for Nisin Drug Substance and Re-TainTM finished drug product.