FDA WARNING_LETTER - AGROINDUSTRIAS MORA S.A - October 20, 2012

The FDA inspected Agroindustrias Mora S.A.'s produce harvesting and packing house in Santa Rosa Oreamuno, Costa Rica, on October 19-20, 2012. The inspection revealed objectionable conditions and practices, leading to the issuance of an FDA-483 and rendering the firm's foods adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. The firm's subsequent response, providing images without descriptions or completion dates, was deemed inadequate. Key violations included: water runoff from a hog pen flowing near young carrots, lack of readily accessible sanitary facilities for workers, wastewater leaking from a septic tank along carrot rows, and dumping carrots into dirty untreated water. Additionally, the firm was observed using carbendazim as a pesticide, which adulterates products under Section 342(a)(2)(B) and 346a(a) of the Act, as no tolerance is established for this pesticide, making treated products unsafe for sale in the U.S. Agroindustrias Mora S.A. must respond within fifteen working days, detailing specific corrective actions with documentation and timelines. Failure to adequately respond could result in further FDA action, including refusal of admission for imported produce under Section 801(a), detention without physical examination (DWPE), and placement on Import Alerts. The firm is responsible for ensuring full compliance with FDA regulations.