FDA WARNING_LETTER - Mendoza Food Products, Inc. - September 07, 2007

On September 6-7, 2007, the FDA inspected Mendoza Food Products, Inc. in Dallas, Texas, and found serious violations of the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations (21 CFR Part 123). The firm's dried and ground shrimp products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "Act") because they were prepared, packed, or held under insanitary conditions.

The primary violation was the firm's failure to have and implement a written HACCP plan for dried shrimp and ground shrimp to control the food safety hazard of sulfites, as required by 21 CFR 123.6(a) and (b). Additionally, the "El Gordo" brand Whole Shrimp product (1oz) was misbranded under section 403(i)(2) of the Act, failing to declare all ingredients (specifically, added salt) as required by 21 CFR 101.4.

The FDA advised the firm to consider identifying products as "dried" in the statement of identity (21 CFR 101.3(b)) and to ensure all required label information appears in English and any foreign language used (21 CFR 101.15(c)).

Mendoza Food Products, Inc. must respond in writing within fifteen working days,