FDA EIR - ReConserve of Colorado, Inc - June 11, 2019

An FDA inspection of ReConserve of Colorado Inc., located in Denver, CO, was conducted from June 10-11, 2019. The inspection, part of the FY2019 Current Good Manufacturing Practice and Preventive Controls for Animal Food Inspections program, focused on the manufacturing of dried bakery product (DBP) for animal feed. The inspection identified significant issues, resulting in the issuance of a Form FDA 483, Inspectional Observations, to General Manager Chris S. Hall. The primary observation was the firm's failure to document verification activities for a critical processing step designed to control biological hazards. Discussion items further highlighted the need for the company to update its Hazard Analysis to align with current regulatory requirements for a "food safety plan" and "preventive controls," moving beyond the outdated HACCP framework. This update requires more specific details for monitoring and corrective actions, including validation of the process by identifying specific pathogens. Additionally, the firm failed to document employee training, and it was recommended that the General Manager receive specific food safety training. Management acknowledged the observations, committed to corrections, and pledged to submit a written response to the FDA within 15 business days. The firm was advised that its response would influence any potential follow-up actions by the agency.