FDA 483 - Grace Kennedy Foods USA LLC - September 23, 2025

This FDA Form 483 document details inspectional observations made at an unspecified food facility between September 19 and September 23, 2025. The inspection identified critical deficiencies in the firm's food safety management systems, primarily concerning the control of hazardous substances.

The main violation highlighted was the absence of a written Hazard Analysis and Critical Control Point (HACCP) plan. This plan is crucial for managing food safety hazards reasonably likely to occur, specifically regarding the receipt and storage of refrigerated ingredients. The firm lacked a plan to control the growth and toxin formation of Clostridium botulinum, a significant risk for certain refrigerated products.

Additionally, monitoring procedures at the receiving step were found inadequate. The practice of merely taking the temperature of refrigerated ingredients upon receipt was deemed insufficient to ensure consistent temperature control throughout transit. This deficiency could compromise product safety before it reaches the facility.

Issued pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act, these observations indicate practices that could affect food safety. While the 483 itself does not mandate specific actions, the firm is expected to address these findings by developing and implementing appropriate corrective actions for FDA review.