FDA EIR - Jumex Mexicali S.A. de C.V. - April 04, 2019

An FDA inspection of Jumex Mexicali S.A. de C.V., a manufacturer and exporter of nectar beverages, was conducted on April 4, 2019. The inspection, part of FY19 Foreign Food Inspection Trip, followed the Acidified Food Inspectional Program (CP 73.03803A) and the Preventive Controls Human Food Current Good Manufacturing Practices Inspection Program (03014). The company produces canned and aseptic tetra pack nectar beverages for distribution in the United States and other regions. The inspection revealed no objectionable conditions, and no FDA 483 form was issued. The primary discussion point was the regulatory applicability of 21 CFR 117 (Preventive Controls for Human Food) for products not covered by 21 CFR 120 (Juice HACCP). Company management acknowledged this and stated they were actively developing the necessary procedures and documentation to comply. A minor observation, not warranting a citation, involved an employee manually handling peach puree with arm guards, raising a discussion about potential physical contamination, which management agreed to address by seeking improved methods. The firm maintains a valid FDA registration and was provided with Food Safety Modernization Act information.