Inspections, Compliance, Enforcement, and Criminal Investigations
National Honey, Inc., dba National Commodities, Co 18-Jul-06
Department of Health and Human Services
Public Health Service
Southwest Import District
July 18, 2006
Via Federal Express
Jun Yang, President
National Honey, Inc., dba National Commodities, Co.
2825 Wilcrest Drive, Suite 155
Houston, TX 77042
Dear Mr. Yang:
We inspected your seafood importer establishment, located at 2825 Wilcrest Drive, Suite 155, Houston, Texas, on June 1, 2006. 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. Because our inspection identified serious violations of 21 CFR Part 123, your frozen whole cooked crawfish 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.
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 may be injurious to health or have been processed under insanitary conditions; and (2) affirmative steps. However, your firm does not have any written verification procedures and did not perform an affirmative step for the frozen whole cooked crawfish manufactured by Shanghai Hong Yea Foods Co., in Shanghai, China.
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