- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Renfen Qiu
- Min Jiang Food Store, Inc. DBA Koi Koi Trading Inc.
1146 S Vail Avenue
Montebello, CA 90640-6021
- Issuing Office:
November 8, 2016
Dear Mr. Qiu,
We inspected your seafood importer establishment, located at 1146 S Vail Avenue, Montebello, CA on May 18, 19 & 20, 2016. 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 123.1 2(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 crab sections (i.e., cooked), frozen scallop wings salad, frozen flying fish roe, frozen cooked short necked clams, and frozen whole crawfish 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.
On June 8, 2016, we received your written responses to our inspectional observations. Your response did not provide evidence to show that you had received HACCP documents from the manufacturers / shippers of your imported fish and fishery products. Based on the review of the documents you provided, your fish and fishery products continue to be adulterated.
Your significant violations were as follows:
- You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation, to comply with 21 CFR123.12(a)(2)(ii). However, your firm did not implement affirmative steps for the following seafood products from China:
• Frozen crab sections (i.e., cooked), imported from Dongshan Xinfu Aquatic Processing Co.
• Frozen scallop wings salad, imported from Time Seafood (Dalian) Co, China
• Frozen flying fish roe, imported from New World (Fuzhou) Agriculture
• Frozen cooked short necked clam, imported from Dandong Galicia Seafood Co.
• Frozen crab sections (i.e., cooked), imported from Dongshan Dongsheng Food Co.
• Frozen whole crawfish, imported from Hubei Chuyu Food Co.
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:
Director, Import Operations Branch
U.S. Food & Drug Administration
One World Trade Center, Suite 300
Long Beach, CA 90831
If you have questions regarding this letter, please contact James R. Miller, Compliance Officer at (562) 256-9211.
CDR Steven E. Porter Jr.
Los Angeles District Director