Inspections, Compliance, Enforcement, and Criminal Investigations
Gusto Food, Inc.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New York District
158-15 Liberty Avenue
Jamaica, NY 11433
August 5, 2009
WARNING LETTER NYK 2009-13
Sompoch Uamploy, President
Gusto Food, Inc.
810 East 27th Street
Paterson, NJ 07513
Dear Mr. Uamploy:
We inspected your seafood importer establishment, located at 5109 Grand Avenue, Maspeth, NY 11378 on March 12 & 18, 2009. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer offish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your frozen steamed mackerel is adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
It has come our attention that your firm has relocated from the facility we inspected at 5109 Grand Avenue, Maspeth, NY 11378 to 810 East 27 Street, Paterson, NJ 07513. The following violations are still applicable to your firm if, your firm continues to import seafood products. If your firm has stopped importing seafood products please inform us using the contact information provided below. According to your firm's new address you are now in the jurisdiction of the of the FDA's New Jersey District Office any further follow up or corrective actions will be conducted or reviewed by the New Jersey District Office.
Your significant violations were as follows:
1. You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12 (a)(2)(i). However, your firm does not have a product specification for your frozen steamed mackerel, specifically to address the histamine hazard and the pathogen hazard.
2. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123. 12 (a)(2)(ii). This affirmative step must provide adequate evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that are equivalent to those required of domestic processors, to comply with 21 CFR 123.12(d). However, your affirmative step which is maintaining on file a copy of the foreign processor's HACCP plan for your steamed mackerel, in accordance with 21 CFR 123.12(a)(2)(ii)(D) is not adequate because you are not maintaining a written letter of guarantee from the foreign processor to verify that the products were processed in accordance with requirements of the seafood HACCP regulation. In addition, the plan itself does not list the significant hazard of histamine development, which a reasonably likely hazard that would need to be controlled consistent with all processors both foreign and domestic.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm's affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should 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 your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention: New Jersey District Office, Director of Compliance, Nancy Rolli, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054. If you have questions regarding any issues in this letter, please contact Ms. Rolli at (973) 331-4902.
Otto D. Vitillo
cc: Mr. Kit Sirichartchai, Vice President
810 East 27th Street
Paterson, NJ 07513