FDA 483 - Kraft Heinz Food Company - September 26, 2025

During an FDA inspection conducted from September 23 to September 26, 2025, a firm, whose name is redacted in the document, received an FDA Form 483 detailing significant observations related to facility sanitation and operational practices. The inspection revealed four primary issues indicating potential non-compliance with the Federal Food, Drug, and Cosmetic Act. Firstly, the plant's construction and design were found inadequate for sanitary operations and maintenance, with observations including air gaps in doors and a leaking pipe in the processing room. Secondly, equipment and utensils were not designed or maintained to prevent contamination, evidenced by a cooler in the processing room leaking condensate. Thirdly, the plant was not kept in a clean and sanitary condition, with standing water observed between dock doors. Finally, the firm failed to properly implement its sanitation verification procedures, as sanitation records for key equipment showed incomplete inspections where 'Pass/Fail' boxes were unchecked, yet the equipment was released for operation. These observations, issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, indicate conditions where products could be prepared, packed, or held under insanitary circumstances. The firm is expected to address these deficiencies by implementing effective corrective actions to ensure compliance with regulatory standards.