FDA EIR - BARCEL, S.A. DE C.V - August 14, 2018

An FDA inspection of Barcel S.A. de C.V. in Lerma, Estado de Mexico, was conducted from August 13-14, 2018. This comprehensive initial inspection, performed by the Dedicated Foreign Food Cadre, aimed to assess the snack food manufacturer's compliance with applicable sections of modernized Current Good Manufacturing Practices (cGMP) under 21 CFR 120 and 117 Subparts A, B, and F. The regulatory guidance for this assessment was derived from Compliance Program 7303.803, Domestic Food Safety. During the two-day inspection, which included observations of manufacturing processes for items like flavored peanuts, tortilla chips, and popcorn, as well as reviews of raw ingredient, finished product, and water analysis reports, no significant objectionable conditions were identified. Consequently, no Form FDA 483, Inspectional Observations, was issued to the Plant Manager, Mr. Cuauhtémoc Contreras Guevara, or any other firm personnel. The inspection team also discussed the Food Safety Modernization Act (FSMA) with company management, providing resources and fact sheets related to its final rules on preventive controls, mitigation strategies, and sanitary transportation. As no violations were found, no specific corrective actions were required from Barcel S.A. de C.V. The firm has no prior inspectional or regulatory history with the FDA.