FDA 483 - Agropur, Inc. - December 07, 2023

Agropur, Inc. in Weyauwega, WI, received a Form 483 following an FDA inspection that identified three observations. The inspection revealed issues with equipment and utensil design and maintenance, including excessive wood debris and cracked lids, which could lead to product contamination. Additionally, the firm failed to protect raw materials from contamination and did not properly implement its sanitation monitoring procedures, lacking supervisory oversight.