Roxy Trading Inc – FDA Warning Letter, Oct 21, 2009

On March 24, 2010, the FDA issued a Warning Letter to Roxy Trading Inc. for re-importing adulterated Sweet Plait Biscuits. The product was initially detained on July 22, 2008, and refused entry on December 1, 2008, due to the presence of Rhodamine B, a non-permitted color additive and suspected carcinogen, violating Sections 402(c), 801(a)(3), and 721(a) of the Federal Food, Drug, and Cosmetic Act. The refused biscuits were stamped "REFUSED Dec 11, 2008 FDA LOS-DO" and processed for export.

However, on April 2, 2009, another shipment of Sweet Plait Biscuits from the same consignee was sampled and also found to contain Rhodamine B, leading to refusal on June 22, 2009. An FDA inspection on October 21, 2009, revealed that previously refused "FDA Refused" Sweet Plait Biscuits were re-imported. Some master cartons showed deliberate manipulation, with missing sections where the "REFUSED" stamp would have been.

Roxy Trading Inc. is responsible for ensuring all imported products comply with the Act, including not introducing adulterated products or those previously refused entry. The FDA warns that failure to correct these violations may result