U-Can Food Trading, Inc. MARCS-CMS 650733 —
- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameChon Chung How
- U-Can Food Trading, Inc.
1620 N. Indiana Street
Los Angeles, CA 90063-2522
- Issuing Office:
- Division of West Coast Imports
January 23, 2023
Re: CMS # 650733
Dear Mr. How:
We inspected your seafood importer establishment, U-Can Food Trading Inc., located at 1620 N. Indiana Street, Los Angeles, CA 90063-2522 on November 30, 2022. 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 imported Jellyfish products (salted Jelly Fish whole, salted Jelly Fish shredded, and salted Jelly Fish head) and Shrimp Paste are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that they have been 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.
We acknowledge receipt of your firm’s response to the Form FDA 483, issued at the close of our recent inspection on November 30, 2022. Your response does not adequately address our observations and we address your response below.
Your significant violations are as follows:
You did not comply with 21 CFR 123.12(a)(2) in that you do not have or have not implemented written verification procedures, product specifications, and an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation. Specifically,
- Your firm did not have written verification procedures, product specifications, and affirmative steps for the Shrimp Paste imported from (b)(4) under Entry HK1-2203184-0. We acknowledge in your December 29, 2022 response, you provided written verification procedures, product specifications, and affirmative steps for the Shrimp Paste you imported from (b)(4). However, your affirmative step is not adequate. The provided certificate did not specify any documentation or certification that the Shrimp Paste was processed in accordance with FDA’s requirements or FDA Seafood HACCP regulation under 21 CFR 123. Furthermore, your provided analytical summary of a laboratory report, dated March 16, 2022, is not adequate to satisfy the affirmative step because it was not accompanied by a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of Part 123. Additionally, the certificate and laboratory report reference a different firm than the foreign processor transmitted as the manufacturer under the entry HK1-2203184-0 without any justification or explanation.
- Your firm did not have written verification procedures, product specifications, and affirmative steps for the Salted Jelly Fish Whole, Salted Jelly Fish Shredded, and Salted Jelly Fish Head imported from (b)(4) under Entry HK1-2203088-3. Your submitted response did not address these imported products.
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: Attention: Juliane Jung-Lau, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502, with a copy via electronic mail to WCID@fda.hhs.gov. Please reference CMS # 65033. If you have any questions regarding any issues in this letter, you may contact Ms. Jung-Lau via email at 510-337-6793 or via email to Juliane.Jung-Lau@fda.hhs.gov.
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports