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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gourmet Express Marketing, Inc. 2/16/10

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5663

February 16, 2010


WARNING LETTER
CHI-04-10


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Patrick Bruno
President
Gourmet Express Marketing, Inc
920 West Fullerton Avenue
Addison, Illinois 60101


Dear Mr. Bruno:


The Food and Drug Administration (FDA) inspected your seafood processing facility, located at 920 West Fullerton Avenue, Addison, Illinois 60101, on August 18 through September 30, 2009 and November 24-25, 2009. We found that you have serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and associated regulations. You can find the Act and regulations on FDA's website at www.fda.gov.


FDA collected samples of your frozen cooked shrimp and frozen easy peel uncooked shrimp products during the inspection of your facility. These frozen shrimp products are adulterated within the meaning of Section 402(b)(4) of the Act [21 U.S.C. § 342(b)(4)], in that an ice glaze has been added to increase the products' bulk or weight. Section 402(b)(4) of the Act provides that a food is adulterated if any substance has been added or packed with it to increase its bulk or weight. Furthermore, your frozen cooked shrimp and frozen easy peel uncooked shrimp are misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], and Section 4(a)(2) of the Fair Packaging and Labeling Act (FPLA) [15 U.S.C. § 1453(a)(2)], in that they fail to bear an accurate statement of the net quantity of contents because they include the weight of the ice glaze in the net quantity of contents.


Section 403(e)(2) of the Act and Section 4(a)(2) of the FPLA require food to bear an accurate statement of the net quantity of contents. Overstating the net quantity of contents (such as including the weight of ice glaze) misbrands the products under these sections, as discussed in FDA's 1991 letter to seafood manufacturers regarding the fraudulent practice of including glaze (ice) as part of the weight of frozen seafood. You can find the letter on FDA's website at: 

http://www.fda.gov/Food/GuidanceCompliance

RegulatorylnformationlGuidanceDocuments/Seafood/ucm123018.htm#contact.


In addition, FDA collected samples of your product labeled as "Pacific Snapper" or "Red Snapper" during the inspection of your facility. This product is adulterated within the meaning of Section 402(b)(2) of the Act [21 U.S.C. § 342(b)(2)] in that Ocean Perch has been substituted for Pacific Snapper or Red Snapper. Furthermore, your product labeled as "Pacific Snapper" or "Red Snapper" is misbranded within the meaning of Section 403(b) of the Act [21 U.S.C. § 343(b)] in that it is offered for sale under the name of Pacific Snapper or Red Snapper but is, in fact, Ocean Perch.


You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.


You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.


This letter may not list all the violations at your facility. You are responsible for ensuring that you are in compliance with all FDA regulatory requirements and that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act, the FPLA, and all applicable regulations.


Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, at the address above. If you have any questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225.


Sincerely,

/S/
Scott J. MacIntire
District Director