FDA 483 - Anhui Hanbon Daily Chemical Co., Ltd. - February 28, 2025

During an inspection conducted from July 19-26, 2016, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Todd's Inc., a ready-to-eat food manufacturer in West Valley City, UT. The inspection revealed several significant observations related to violations of Current Good Manufacturing Practice (CGMP) regulations, specifically 21 CFR Part 110.

Key issues included a failure to maintain sanitary conditions and controls to prevent microbial growth and contamination. Inspectors observed condensation dripping onto uncovered food, employees spraying debris near ingredients, and improper hand hygiene practices such as touching contaminated surfaces before handling food. The facility also exhibited widespread unsanitary conditions, including food debris, mold-like residue, and rust on equipment, as well as standing water and residue on floors and drains. Equipment cleaning and sanitization procedures were found inadequate, with food debris remaining on a dicer blade after cleaning and residue on conveyor belts. Furthermore, the firm failed to protect against pests, evidenced by an open back door and flies in the processing area. Personnel hygiene practices were also deficient, with employees not wearing appropriate protective attire or adhering to proper handwashing protocols. Finally, the firm's environmental monitoring program for Listeria monocytogenes was deemed insufficient, lacking robust testing of food-contact surfaces and adequate sampling frequency.

Todd's Inc. is required to address these observations by implementing comprehensive corrective actions to ensure full compliance with FDA's food safety regulations.