FDA WARNING_LETTER - Gourmet Express Marketing, Inc. - November 25, 2009

On August 18-September 30, 2009, and November 24-25, 2009, the FDA inspected Gourmet Express Marketing, Inc.'s seafood processing facility. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and associated regulations.

Frozen cooked shrimp and frozen easy peel uncooked shrimp products were found to be adulterated under Section 402(b)(4) of the Act, as an ice glaze was added to increase bulk or weight. These products were also misbranded under Section 403(e)(2) of the Act and Section 4(a)(2) of the Fair Packaging and Labeling Act (FPLA) because the net quantity of contents included the weight of the ice glaze, leading to an inaccurate statement of net quantity.

Additionally, products labeled as "Pacific Snapper" or "Red Snapper" were found to be adulterated under Section 402(b)(2) of the Act, as Ocean Perch had been substituted. These products were also misbranded under Section 403(b) of the Act for being offered for sale under a false name.

Gourmet Express Marketing, Inc. must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory action, including seizure and/or injunction. A written response outlining specific corrective actions is required