Inspections, Compliance, Enforcement, and Criminal Investigations

Bao International Inc 1/30/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Los Angeles District
19701 Fairchild,
Irvine CA 92612-2506
Telephone: 949-608-2900
Fax: 949-608-4417 

 

WARNING LETTER
WL# 14-17
  
 
VIA UNITED PARCEL SERVICE
 
 
January 30, 2017
 
 
Edmund F. Tsang, President
Bao International Inc.
4553 Castle Rd.
La Canada, Ca. 91011-1452
 
Dear Mr. Tsang:
 
We inspected your seafood importerestablishment, located at 4553 Castle Rd. La Canada, Ca. 91011-1452 on December 13, 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 (21CFR 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 21CFR 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 breaded squid ring and tentacles and frozen seafood mix 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 received your written response dated January 10, 2017 which included Product Specifications and Importer Written Verification Procedures for the frozen breaded squid ring and tentacles and frozen seafood mix.  However, your product specifications failed to identify the hazards that are specific to the product.  The Importer Written Verification Procedures provided identify that you are obtaining a continuing or lot-by-lot certificate from a competent third party certifying that the imported fish or fishery product  is or was processed in accordance with the requirement of this part, however, you failed to provide the certificate specific to the lot for Entry Number (b)(4) Frozen Breaded Squid Ring and Tentacles and Entry Number (b)(4) Frozen Seafood Mix.  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 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 you import are processed in compliance with the Seafood HACCP regulation.  Specifically, you failed to provide adequate product specifications and an affirmative step for the following products:
o     Frozen Breaded Squid Ring and Tentacles manufactured by (b)(4)
o     Frozen Seafood Mix 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 inevaluating 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 listall 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 any questions regarding this letter, please contact Terrance Nguyen, Acting Compliance Officer, at (562) 256-9212.
 
Sincerely,
/S/
CDR Steven E. Porter Jr.
Los Angeles District Director
 
 
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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