Inspections, Compliance, Enforcement, and Criminal Investigations
Zhong Shun Inc. 3/7/12
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Los Angeles District
VIA UNITED PARCEL SERVICE
March 7, 2012
Mr. Kevin Fang, General Manager
Zhong Shun Inc.
18605 Gale Ave., #245
City of Industry, CA 91748
Dear Mr. Fang:
We inspected your seafood importer establishment located at 18605 Gale Ave., #245, City of Industry, CA 91748 on December 13, 2011. 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. Our inspection identified serious violations of 21 CFR Pmt 123; therefore, your frozen roasted eel 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:
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 product specifications for the frozen roasted eel that your firm imports from China.
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). However, your firm did not perform an affirmative step for the frozen roasted eel that your firm imports from China.
In addition, we advise your firm that as the importer of record, it is your responsibility to hold the product intact until it is released by the FDA. Your firm has an ongoing responsibility to ensure that all import brokers, consignees and others working on your behalf hold the imported product intact until it is authorized by FDA for release, destruction, or exportation. We remind you that distribution of products in violation of the Federal Food, Drug and Cosmetic Act into interstate commerce may result in seizure of the products and may also result in regulatory action taken against you such as injunction or prosecution.
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 processing plant 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 any other violations of the Act and all applicable regulations.
A copy of this letter) except for any confidential, personal, or commercial information, will be placed on public display no earlier than fifteen (15) days after the date of this letter. Your response will be on public display with any confidential, personal, or commercial information purged.
Please send your reply to the Food and Drug Administration, Attention: Dr. James Lin, 222 N. Sepulveda Blvd., Suite 740, El Segundo, CA 90245. If you have questions regarding any issues in this letter, please contact Dr. James Lin at 310-647-2923.
Alonza Cruse, Director
Los Angeles District
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413