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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ching Jiang Fisheries Products, Inc. 8/27/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Import Operations Branch
Los Angeles District
222 W. Sixth Street. Suite 700
San Pedro, CA 90731-3354
Telephone: 310-971-2280
Fax:             310-971-2360 

 

WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
           
                                                                                                                              
August 27, 2013
WL # 51-13
Mr. Charles Q. Yi, Owner
c/o Ching Jiang Fisheries Products, Inc.
150 N Santa Anita Blvd, Suite 500
Arcadia, CA 91006
 
                                                           
Dear Mr. Yi:
 
We inspected your seafood importer establishment, located at 150 N Santa Anita Blvd, Suite 500, Arcadia, CA 91006 between June 18 and June 24, 2013.  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 Pacific Cod Fillets, frozen Arrowtooth Flounder Fillets, and frozen Alaskan Pollock Fillets 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.
 
Your significant violations were as follows:
 
  • You did not implement an affirmative step which ensures that the fish and fishery product you import are processed in accordance with the seafood HACCP regulation, 21 CFR 123.12(a)(2)(ii). Specifically, your firm did not have an affirmative step for the frozen Pacific Cod Fillets manufactured by (b)(4) or the frozen Arrowtooth Flounder Fillets and frozen Alaskan Pollock Fillets manufactured by (b)(4).
  • You did not comply with 21 CFR 123.12(a)(2)(i) in that you did not have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health or have not been processed under insanitary conditions. Specifically, your firm did not have product specifications for the frozen Pacific Cod Fillets manufactured by (b)(4) or the frozen Arrowtooth Flounder Fillets and frozen Alaskan Pollock Fillets manufactured by (b)(4).
 
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:
 
US Food and Drug Administration
Attention: Daniel Solis, Director
Import Operations Branch
Los Angeles District
West 6th Street, Suite 700
San Pedro, CA 90731                                     
 
If you have any questions regarding this letter, please contact Carla Fernandez Borges, Compliance Officer,at (310) 971-2373.
 
Sincerely,
/S/                                                                                 
Alonza E. Cruse, Director
Los Angeles District 
 
 
Cc:      
Mr. Charles Q. Yi, Owner
c/o Ching Jiang Fisheries Products, Inc.
P.O. Box 660605
Arcadia, CA 91066