FDA WARNING_LETTER - Organizaciion Agricultores Bo. Espino - July 03, 2008

The FDA inspected Organizacion Agricultores' fruit beverage and pulp processing facility in San Lorenzo, PR, on June 27, 30, and July 3, 2008, identifying serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 120. These violations render the firm's tamarind, passion fruit, and caribbean cherry fruit pulps and beverages adulterated under the Federal Food, Drug, and Cosmetic Act. Key violations include the firm's failure to pasteurize fruit pulps, instead relying on beverage pasteurization as a Critical Control Point (CCP) for microbiological hazards. Crucially, the firm failed to maintain adequate records documenting the monitoring of critical control points and their critical limits, as required by 21 CFR 120.12(a)(4)(i). This included a complete absence of pasteurization records for February-April 2008, and existing records that were blank, illegible, or lacked essential temperature/time gradients. Furthermore, the firm did not maintain sanitation control records documenting monitoring and corrections for food contact surfaces and equipment, as mandated by 21 CFR 120.6(c) and 120.12(a)(1), with the most recent record dating back to February 2008 despite ongoing operations. The FDA requires a written response within fifteen working days detailing specific corrective actions and supporting documentation. Failure to promptly address these issues may result in further regulatory action, including product seizure or an injunction against the firm's operations. The firm is responsible for ensuring full compliance with all applicable regulations.