FDA WARNING_LETTER - Richies Produce Inc.

On June 3, 2015, Richies Produce, Inc. imported Dasheen (Yautia Lila). The FDA detained this product on June 9, 2015, because a previous shipment from the same grower in April 2015 was found to contain Trifloxystrobin and Cyprocozole, pesticides without tolerance, rendering the product adulterated under Section 402(a)(2)(B) of the Federal Food Drug and Cosmetic Act.

On July 6, 2015, the FDA refused the June 3rd shipment after private laboratory analytical results confirmed the presence of Cyprocozole. On July 8, 2015, U.S. Customs Border Protection (CBP) issued a Notice to Redeliver. Despite this refusal and redelivery notice, Richies Produce, Inc. partially distributed the shipment into U.S. commerce for consumption without FDA release on July 16, 2015.

This action violates 21 CFR Section 1.90, which requires importers to hold imported articles pending FDA examination results or release. The firm's failure to hold the adulterated Dasheen intact and its premature distribution constitute a prohibited act under Section 301(c) of the Act.

The FDA requires a written response within fifteen working days outlining specific corrective steps taken to prevent future premature distribution of imported goods subject to FDA