Inspections, Compliance, Enforcement, and Criminal Investigations
Fulton Seafood Inc 24-Sep-08
Department of Health and Human Services
Public Health Service
Southwest Import District
September 24, 2008
Via Federal Express
Le Huynh, President
Fulton Seafood Inc.
2818 McKinney St
Houston, Texas 77003-3732
Dear Ms. Huynh:
We inspected your seafood importer establishment, located at 2818 McKinney St, Houston, Texas, on June 13, 16 & 17, 2008. 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 of fish 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. Additionally, your Canned Sardines in Tomato Sauce product will be considered 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.
Your significant violations were as follows:
You must have and implement written verification procedures for ensuring that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2). The procedures shall list, at a minimum: (1) product specifications designed to ensure that the product is not adulterated under the Act because it maybe injurious to health or have been processed under insanitary conditions, and (2) affirmative steps. Your firm uses the foreign manufacturer's HACCP plan as an affirmative step, which appears to be inadequate to assure that the products are not adulterated. Specifically, the HACCP plan provided by the manufacturer, [(b)(4)] located in [(b)(4)] lacks information on the steps needed to control histamine formation during the raw material storage step.
Additionally, the HACCP manual does not contain a written guarantee from the foreign processor of the canned Sardines in Tomato Sauce.
FDA also collected a sample from this processor that was offered for entry in Houston, TX by your firm on April 01, 2008, under entry # [(b)(4)]. The sample collected by FDA personnel on April 15, 2008 was found violative for Histamines in three subsamples (Sub-sample: #8:131.0 ppm; #9:248.5 ppm; #12:124.7 ppm) and subsequently detained on May 15, 2008. The entry was refused admission on June 05, 2008.
Both our inspection and the above sample collected under entry number [(b)(4)], indicate that the foreign firm's HACCP plan is inadequate to control Histamines.
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: Lisa M. Puttonen, Compliance Officer, Southwest Import District, 4040 North Central Expressway, Dallas, Texas, 75204. If you have questions regarding any issues in this letter, please contact Ms. Puttonen at 214-253-5285.
Robert J. Deininger
Southwest Import District