FDA 483 - POET Corning Bioprocessing LLC - July 26, 2023

An FDA inspection of POET Corning Bioprocessing LLC in Corning, IA, on July 26, 2023, revealed a significant deficiency in the firm's preventive controls. The company failed to identify and implement adequate controls to minimize hazards, specifically concerning the statistically and scientifically unrepresentative sampling of incoming whole grain corn used in their products for cattle and swine. This indicates a serious lapse in ensuring product safety and quality.