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  5. N.A. Sales Company Inc. - 05/16/2016
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WARNING LETTER

N.A. Sales Company Inc. May 16, 2016

N.A. Sales Company Inc. - 05/16/2016


Recipient:
N.A. Sales Company Inc.


United States

Issuing Office:
San Francisco District Office

United States


  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Telephone:     510-337-6700

 

WARNING LETTER
 
 
May 16, 2016                                                                                                 
 
VIA UPS
 
Tetsuo Mochizuki, President
N.A. Sales Company, Inc.
301 East Grand Avenue
South San Francisco, CA 94080
 
Dear Mr. Mochizuki:
 
We inspected your seafood importer establishment, located at 301 East Grand Avenue, South San Francisco, CA, on April 4, 2016 through April 6, 2016 We found that you have a 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 products have 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. Our inspection identified serious violations for 21 CFR Part 123; therefore, your dried sardine & mackerel, shaved mackerel & scad, dried shaved bonito, frozen prepared pacific herring, frozen breaded horse mackerel, frozen yellowtail, frozen dried small sardine, frozen pacific squid, frozen cuttlefish, frozen monkfish, frozen dried jack mackerel, frozen dried fling fish, frozen dried pacific sand lance, and frozen red seabream loins imported from Japan 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 are as follows:
  1. You must have product specifications that are designed to ensure that the fish and fishery products that you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i).   However, your firm imports a variety of frozen, and dried seafood products including the following: frozen red seabream loins, frozen yellowtail, frozen pacific squid, frozen cuttlefish, frozen monkfish, frozen breaded horse mackerel, frozen prepared pacific herring, dried shaved mackerel & scad, dried sardine & scad, and dried shaved bonito and you do not have product specifications to address the hazards of histamine; environmental chemicals; aquaculture drugs; potential metal inclusion; undeclared food allergens/food additives; and pathogen growth and potential toxin formation including, for example, Clostridium botulinum and Staphylococcus aureus toxin formation.
  1. You must implement an affirmative step designed to ensure that the fish and fishery products that you import into the United States were processed in accordance with the requirements of FDA's seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii).  However, your firm did not implement an affirmative step for the importation of your, pacific herring, frozen breaded horse mackerel, frozen dried small sardine, frozen farm raised yellowtail, frozen pacific squid, frozen cuttlefish, frozen monkfish, frozen dried jack mackerel, frozen dried flying fish, prepared pacific san lance, and frozen red seabream loins imported from (b)(4), Tokyo, Japan; or the dried sardine & mackerel, dried shaved mackerel & scad, and dried shaved bonito, imported from (b)(4), Tokyo, Japan. 
For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
 
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.
 
We may take further action if you do not promptly correct this violation. 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.
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
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.
 
Please send your reply to the Food and Drug Administration, Attention: Lawton W. Lum, Director of Compliance 1431 Harbor Bay Parkway, Alameda, CA 94502 and reference CMS number 496016 in your reply. If you have any questions regarding any issues in this letter, please contact Compliance Officer Sergio Chavez at (510) 337-6886.
 
 
Sincerely,
/S/ 
Kathleen M. Lewis, J.D.
District Director
San Francisco District