FDA EIR - Ridley USA Inc. dba Hubbard Feeds, Inc. - June 26, 2018

Hubbard Feeds Inc. underwent an FDA inspection from July 24-26, 2018, initiated as a follow-up to two animal feed recall events (V-0078-2018 and V-0077-2018) that resulted in animal deaths, likely due to Vitamin D deficiency. The inspection, guided by the regulatory framework of 21 CFR Part 507 (Current Good Manufacturing Practice and Preventive Controls for Animal Food), revealed five significant violations documented on an FDA Form 483.

Key issues included the company's failure to implement adequate preventive controls for identified hazards, specifically related to critical vitamin premix addition, despite previous incidents. Records were not consistently created concurrently with production activities, with evidence of post-event alteration. The facility also failed to effectively exclude pests, exhibiting open doors, structural gaps, birds inside the plant, and evidence of rodent activity. Furthermore, the plant was not maintained in a sufficiently clean manner, with accumulations of dust and debris in production and unloading areas, directly risking animal food contamination. Finally, the grounds around the plant were not kept in a condition that would protect against contamination, showing excessive weeds and discarded equipment. An additional observation noted improper identification of rework materials.

Management was advised of the critical need to address these observations, implement robust preventive controls, ensure accurate and timely record-keeping, improve pest control, enhance facility sanitation, and maintain clean premises. Compliance with the Food, Drug, and Cosmetic Act was emphasized, with potential for further enforcement actions if issues persist.