FDA 483 - Wells Enterprises, Inc. - June 15, 2018

Fieldbrook Foods Corporation, a food manufacturer in Dunkirk, NY, was cited for failing to implement a written supply-chain program. This deficiency led to inadequate control over biological hazards, specifically Listeria monocytogenes and salmonella, in a key ingredient used in their evacuated orange cream bars. The firm did not adequately review vendor documentation to ensure these significant food safety hazards were addressed, posing a potential contamination risk.