FDA EIR - Madison County Farm Supply, Inc. - July 03, 2019

An FDA surveillance inspection was conducted at Madison County Farm Supply, Inc. on July 3, 2019, to assess compliance with the Part 507 Current Good Manufacturing Practice (cGMP) regulations for animal food. The inspection covered the receipt, production, and distribution of medicated and non-medicated livestock feed. During the inspection, no formal written observations (FDA Form 483s) were issued. However, two verbal observations were noted during the close-out discussion with management. These included drainage issues in front of the manufacturing structure and an unused loading dock area, which could potentially lead to water ingress. Additionally, an open area below the roofline of the manufacturing structure was identified, requiring enclosure or screening to prevent birds from entering. A significant finding was that the firm's hazard analysis did not establish a preventive control, resulting in the absence of implemented recall procedures, a critical aspect of animal food safety regulations. While no formal actions were mandated, management committed to voluntarily address the drainage and bird exclusion issues. The inspection emphasized management's responsibility to adhere to the Federal Food, Drug, and Cosmetic Act to avoid potential enforcement actions.