El Chilerito Spice Co. Inc. – FDA Warning Letter, Feb 3, 2011

On January 26, 2011, through February 3, 2011, the FDA inspected El Chilerito Spice Co. Inc., concurrently with a USDA-FDA joint investigation, prompted by information from a customer. The inspection covered receiving, storage, labeling, and distribution.

Analyses of five samples of "Pimienton Chorizero" spice from three customers revealed adulteration under section 402(c) [21 U.S.C. § 342(c)] due to unsafe color additives (Cochineal Red A (Ponceau 4R) and Carmoisine), which are not FDA-listed. The product was also misbranded under section 403 [21 U.S.C. § 343] for failing to declare artificial coloring (Sunset Yellow FCF/FD&C Yellow No. 6) as required by 21 CFR 101.22(k).

Further misbranding violations included: - Failure to bear the common or usual name of the food (21 CFR 101.3). - Failure to list common or usual names of all ingredients and sub-ingredients (21 CFR 101.4). - Failure to bear the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). - Failure