FDA 483 - Bende, Inc. - December 22, 2023

An FDA inspection of Bende, Inc. in Vernon Hills, IL, focused on their Foreign Supplier Verification Program (FSVP). The inspection revealed significant issues with the firm's hazard analysis and supplier verification activities, specifically concerning the identification and labeling of wheat as a major food allergen. These deficiencies indicate a failure to adequately control allergen hazards and ensure proper product labeling.