FDA EIR - Hi-Pro Feeds LLC - July 17, 2019

An FDA inspection of Hi-Pro Feeds Inc., located at 1201 E 11th St Friona, TX, was conducted from July 15 to July 17, 2019. This routine inspection, carried out by the Texas Feed and Fertilizer Control Service under the FY 2019 Feed Contract and 21 CFR Part 507 (Current Good Manufacturing Practice and Preventive Controls for Animal Food), aimed to assess the firm's compliance. The inspection resulted in a 1-item FDA 483 form, citing the company for failing to establish a written supply-chain program. Specifically, the firm relied solely on supplier declarations for ingredient safety without verifying received ingredients, despite acknowledging potential risks requiring preventive controls. Beyond the formal observation, several issues were discussed with management. These included a potential rodent entry point at an old loading door, the absence of hot water in the employee washroom, incomplete employee training records where names were not consistently printed, an inaccurate identification of HACCP principle 1 in the Food Safety Plan, and the omission of deoxynivalenol as a potential hazard despite the use of barley and wheat in feed manufacturing. The inspection was classified as Voluntary Action Indicated (VAI). This classification signals that while objectionable conditions were observed, regulatory action is not immediately pursued. Hi-Pro Feeds Inc. is expected to voluntarily address the identified deficiencies, particularly by developing and implementing a robust written supply-chain program with ingredient verification and rectifying the other discussed operational and documentation issues to ensure ongoing compliance and product safety.