FDA 483 - POET Bioprocessing-Emmetsburg LLC - July 25, 2023

POET Bioprocessing-Emmetsburg LLC, a manufacturer of animal feed ingredients, was cited for failing to identify and implement adequate preventive controls. Specifically, the firm's method for sampling incoming whole grain corn for mycotoxin contamination was found to be neither statistically nor scientifically representative. This deficiency indicates a failure to ensure that hazards requiring preventive controls are significantly minimized or prevented.