FDA WARNING_LETTER - Fresh Directions Dominicana S.A. - June 21, 2013

On June 20-21, 2013, the FDA inspected Fresh Directions Dominicana's facility in the Dominican Republic, identifying serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). While the firm adequately addressed CGMP deviations in their July and September 2013 responses, HACCP deviations for frozen mango pulp remained unaddressed.

The primary violation is the failure of the juice HACCP plan for frozen mango pulp to include measures consistently producing a 5-log pathogen reduction, as required by 21 CFR 120.24(a) and (b). The firm's stated pre-requisite programs, including a "chlorine wash" and the product's natural acidity, vacuum-packing, and freezing, were deemed inadequate to achieve the required 5-log reduction. Consequently, the frozen mango pulp is considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The FDA noted the firm's intent to implement a high-pressure processing system by year-end to meet the 5-log reduction, emphasizing the need for verification, validation, and HACCP plan updates. The firm must respond within 15 working days with documentation of corrections, including a revised HAC