FDA 483 - Krispy Kreme - June 03, 2025

Krispy Kreme's facility at 315 Wilshire Ave SW was inspected by the FDA from June 2-3, 2025, resulting in an FDA Form 483 with two key observations. The inspection was conducted under the Federal Food, Drug, and Cosmetic Act, focusing on food safety and regulatory compliance.

The primary issue noted was the failure to exclude pests from the food plant. Specifically, a frog was observed on an extruder during the production of Ready-to-Eat (RTE) mini original glazed doughnuts, indicating a significant lapse in pest control that could lead to product contamination.

Secondly, the firm's preventive controls records were found to be deficient. Observations included a Critical Control Point (CCP) record with an unaddressed deviation (a line through an entry without documented corrective action), quality check records using tick marks instead of actual values, and a glaze, filling, and icing lot tracking sheet missing crucial details such as shift, line, and verification signatures. These record-keeping issues suggest a lack of proper documentation for food safety controls.

Krispy Kreme is required to address these observations by implementing comprehensive corrective actions to enhance pest exclusion and ensure all food safety records are accurate, complete, and compliant with regulatory requirements.