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WARNING LETTER

Daesang America Inc MARCS-CMS 520294 —

Recipient:
Daesang America Inc

United States

Issuing Office:
New Jersey District Office

United States

 

  

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New Jersey District Office
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054 

 

WARNING LETTER
 
 
March 23, 2017
 
 
 
VIA UNITED PARCEL SERVICE                                                                                  17-NWJ-07
 
Peter Yang, Director of Sales
Daesang America, Inc.
1 University Plaza, Suite 603
Hackensack, New Jersey 07601
 
 
Dear Mr. Yang:
 
The U.S. Food and Drug Administration (FDA) inspected your seafood importer facility, located at 1 University Plaza, Suite 603, Hackensack, New Jersey, on February 8 through February 27, 2017. 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 fish cakes (slice, mixed, stick, and hand boiling) 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 homepage at www.fda.gov. The FDA investigator provided you with the form FDA-483, List of Inspectional Observations, at the conclusion of the inspection on February 27, 2017.  
 
While your firm committed to respond to the FDA-483 issued during the inspection, your firm has not yet submitted a written response to address the FDA-483 observations.
 
Your significant violations were as follows:
 
1.    You do not have or have not implemented written verification procedures for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation. The written verification procedures shall list, at minimum: (1) product specifications designed to ensure that the product is not adulterated under the Act because it may be injurious to health or have been processed under insanitary conditions; and (2) affirmative steps. 21 CFR 123.12(a)(2). This violation was noted during the previous inspection in 2013.
 
Specifically, your firm does not have written product specifications or affirmative steps for frozen fish cakes (slice, mixed, stick, and hand boiling), as required by 21 CFR 123.12(a)(2)(i) &(ii).
 
Your firm must properly implement written affirmative steps to ensure that the fish and fishery product(s) that you import are processed in accordance with the seafood HACCP regulation, as required by 21 CFR 123.12 (a)(2)(i) & (ii).
 
2.    You have failed to maintain records that document the performance and results of affirmative steps, as required by 21 CFR 123.12(c) and 123.9.
 
Specifically, you failed to provide documentation that the seafood products that you have imported over the last four years, including but not limited, fish cutlets and fish cakes, are processed according to seafood regulations.
 
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.
 
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 non-compliance, 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.
 
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, 3rd Floor, New Jersey 07054.  If you should have any questions regarding this letter, please contact Andrew Ciaccia, Compliance Officer at 1-973-331-4904.
 
                                                                                                           
Sincerely,
/S/                                                                                                         
Craig Swanson
Acting District Director
New Jersey District

 

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