Inspections, Compliance, Enforcement, and Criminal Investigations

New Ocean Trading (USA) Inc. 1/29/16

  

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
Long Beach Resident Post
One World Trade Center,  Suite 300
Long Beach, CA 90831
Main Phone: (562) 256-7700
Fax: (562) 256-7701

 

WARNING LETTER
 
VIA UNITED PARCEL SERVICE
 
SIGNATURE REQUIRED
WL# 18-16
 

 
January 29, 2016
 
Mr. Michael Guo, Owner and General Manager
New Ocean Trading (USA) Inc.
925 S. Atlantic Blvd., Suite 206B
Monterey Park, CA  91754
 
Dear Mr. Guo,

We inspected your seafood importer establishment, located at 925 S. Atlantic Blvd., Suite 206B, Monterey Park, CA 91754 on October 21, 2015 - October 22, 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 CPR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CPR 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 CPR 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 CPR 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 CPR 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 CPR Part 123, your Frozen Frog Legs, and Frozen Shrimps 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 horne page at www.fda.gov.
 
Your significant violations were as follows:
  • You do not have or have not implemented written verification procedures, product specifications, and an affirmative step for ensuring that the fishery products you import are processed in compliance with the Seafood HACCP regulation, 21 CFR 123.12(a)(2)(i-ii). Specifically, you failed to provide written verification procedures, product specifications, and an affirmative steps for the IQF Frozen Shrimp manufactured by (b)(4); Frozen Frog Legs manufactured by (b)(4); and Frozen Shrimps PND manufactured by (b)(4). For the IQF Frozen Shrimp PND manufactured by (b)(4) you failed to provide written verification procedures and product specifications.
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 William Park, Compliance Officer at (562) 256-9259.
 
Sincerely,
/S/
LCDR Steven Porter, Acting Director
Los Angles District 
 
 
Cc:      
David M. Mazzera, Chief
Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413

 

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