FDA 483 - Wells Enterprises, Inc. - July 12, 2017

An FDA inspection of Fieldbrook Foods Corporation in Dunkirk, NY, from June 13 to July 12, 2017, revealed significant deficiencies in sanitation controls and plant maintenance. The firm failed to adequately monitor and respond to Listeria monocytogenes contamination, maintain sanitary conditions, and prevent cross-contamination, leading to widespread environmental positives and conditions that could compromise food safety.