FDA WARNING_LETTER - Supermercado Econo Inc. E - July 23, 2015

On April 23, 2015, Supermercados Econo, Inc. imported a shipment of Dasheen (Yautia Lila) under Entry 256-0335580-8. FDA laboratory analysis on May 4, 2015, found Trifloxystrobin and Cyprocozole, pesticides with zero or no established tolerance limits, rendering the Dasheen adulterated under Section 402(a)(2)(B) of the Federal Food Drug and Cosmetic Act [21 U.S.C 342 (a)(2)(B)].

Despite a July 23, 2015, refusal notice sent to their U.S. Custom Broker, the firm distributed the shipment into U.S. commerce without FDA release. This violates 21 CFR Section 1.90, which requires importers to hold imported articles pending FDA examination results, a "May Proceed Notice," or a "Notice of Release."

Additionally, the firm failed to comply with a July 23, 2015, Notice to Redeliver (CBP Form 4647) issued by United States Customs Border Protection (CBP), which may result in CBP penalty action. The premature distribution of adulterated Dasheen is a prohibited act under Section 301(c) of the Act (21 U.S.C. 33