Public Health Service Food and Drug Administration
Import Operations Branch Los Angeles District Long Beach Resident Post One World Trade Center, Suite 300 Long Beach, CA 90831 Main Phone: (562) 256-7700 Fax: (562) 256-7701
VIA UNITED PARCEL SERVICE
February 1, 2016
Mr. Frank Zhu (Feng Hua Zhu)
FHZ Trading, Inc.
924 E. Main Street, Suite 119
Alhambra, CA 91801
Dear Mr. Zhu,
We reviewed records regarding the fish products your firm imports on October 7, 2015. 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 for 21 CFR Part 123, your frozen farm raised shrimp processed and packed by (b)(4) and the frozen cleaned crab processed by (b)(4) are adulterated under Section 402(a)(4)of the Act (21 U.S.C. § 342(a)(4)), in that they havebeen prepared, packed, or held under insanitary conditions whereby they 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:
Your firm must have written verification, product specifications, and affirmative steps that are designed to ensure that the fish and fishery products your firm imported are not injurious to health and comply with 21 CFR 123.12. Specifically, your firm does not have written verification, product specifications, and affirmative steps for the frozen farm raised shrimp processed and packed by (b)(4); and the frozen cleaned crab processed by (b)(4).
We acknowledge receipt of the HACCP plans for the frozen cleaned crab and for the frozen farm raised shrimp received via emails from Mr. Mark Teng dated 10/28/15 & 10/29/15 respectively. The HACCP plans alone are not enough to demonstrate compliance with the special requirements for imported products under 21 CFR 123.12. In addition to the processor’s HACCP plan, the processor’s written guarantee or the processor’s sanitation monitoring record is required to be considered an affirmative step to show compliance with 21 CFR 123.12.
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:
Food and Drug Administration
Attention: Daniel Solis
Director Import Operations Branch
Los Angeles District
One World Trade Center, Suite 300
Long Beach, CA 90831
If you have questions regarding this letter, please contact David Serrano, Compliance Officer at(562) 256-9210.