FDA WARNING_LETTER - Harouts Inc. dba Brewing Market Coffee - January 25, 2024

The FDA conducted an inspection of the acidified food manufacturing facility at 5775 Arapahoe Ave, Boulder, Colorado, from December 14, 2023, through January 25, 2024. A finished product sample of Ginger Chai Tea was collected for pH and water activity analysis. The inspection and sample analysis revealed serious deviations from the Emergency Permit Control (21 CFR Part 108) and Acidified Foods (21 CFR Part 114) regulations, leading to the determination that the acidified chai teas are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to provide FDA with scheduled process information for new acidified foods (21 CFR 108.25(c)(2)), lack of FDA-approved training for operators supervising processing and packaging systems (21 CFR 114.10), and insufficient control and recording of finished equilibrium pH values to ensure they are not higher than 4.6 (21 CFR 114.80(a)(2)). Additionally, the facility failed to renew its registration with FDA, a requirement under Section 415(a)(3) of the Act and 21 CFR Part 1, Subpart H, which constitutes a prohibited act under Section 301(dd). The FDA also noted that the facility is subject to the preventive control requirements of 21 CFR Part 117. The firm is required to respond in writing within 15 business days, detailing corrective actions, and must register the facility within 30 working days to avoid potential legal action, including seizure and injunction.