FDA WARNING_LETTER - Tugusto Foods, Inc. - June 07, 2019

The FDA inspected Urb. Industrial Minillas, a manufacturer and repacker of Ready-to-Eat (RTE) seasonings and spices, on May 7-8 and June 7, 2019. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), leading to products being adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Additionally, labeling violations (21 CFR Part 101) caused products to be misbranded under 21 U.S.C. § 343.

Key violations included the firm's failure to prepare and implement a food safety plan, conduct a hazard analysis for pathogens and mycotoxins, and implement effective pest exclusion measures. Significant CGMP deficiencies involved inadequate operational controls to minimize contamination, poor equipment maintenance, insufficient employee handwashing and hygiene practices (e.g., no hair restraints, unsecured jewelry), and inadequate hand-washing facilities. Labeling issues included missing Nutrition Facts, incomplete ingredient lists, improper nutrient content claims, and false/misleading ingredient declarations. The firm's June 26, 2019, response was deemed inadequate for several issues. The FDA requires a written response within 15 working days detailing specific corrective actions, recurrence prevention, and timelines, warning of potential regulatory actions like seizure, injunction, and re-inspection fees.