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WARNING LETTER

DN Imports, Inc MARCS-CMS 609439 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Danh Nguyen
Recipient Title
Owner
DN Imports, Inc

4114 Midstream Dr.
Missouri City, TX 77459-1726
United States

Issuing Office:
Division of Southwest Imports

United States

September 4, 2020

WARNING LETTER


CMS # 609439

Dear Mr. Nguyen,

On May 15, 2020 to June 11, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of DN Imports, Inc., located at 4114 Midstream Dr., Missouri City, TX 77459. We also conducted an inspection on April 20, 2018. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals

During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your mushroom soup powder and seasoning sauce with garlic and chili imported from your foreign supplier (b)(4), and roasted corn imported from your foreign supplier (b)(4). You did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of both the initial inspection in 2018 and the follow-up inspection in 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your email response dated June 21, 2020, in which you stated that in 2019, you went to (b)(4) to inspect several manufacturers who have supplied food to your firm, talked to them about FSVP, and asked them to analyze their foods (b)(4) and send you the test results. We also acknowledge receipt of your email response dated July 29, 2020, stating that you are “planning to do FSVP on all of the products that we import to the USA.” However, we are unable to evaluate your response as it relates to your mushroom soup powder and seasoning sauce with garlic and chili imported from (b)(4), and roasted corn imported from (b)(4), because you did not include supporting documentation.

Your response included your document titled “Food Safety Verification Form” for your “Maggi Soy Sauce Seasoning Concentrate” product. To the extent that you intend for the document “Food Safety Verification Form” to be your FSVP for the Maggi Soy Sauce Seasoning Concentrate you import from (b)(4), you did not meet the FSVP requirements for this product. For example, you did not meet your requirements to conduct a hazard analysis in accordance with 21 CFR 1.504, you did not evaluate your foreign supplier’s performance in accordance with 21 CFR 1.505, nor did you perform foreign supplier verification activities in accordance with 21 CFR 1.506.

Your significant violations of the FSVP regulation are as follows:

You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for each of the following foods:

• Mushroom soup powder imported from (b)(4)., located in (b)(4);
• Seasoning sauce with garlic and chili imported from (b)(4)., located in (b)(4); and
• Roasted corn imported from (b)(4)., located in (b)(4).

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.

You should take prompt action to correct the above violations. If you do not promptly correct them, FDA may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of mushroom soup powder and seasoning sauce with garlic and chili imported from your foreign supplier (b)(4)., located in (b)(4), and roasted corn imported from your foreign supplier (b)(4)., located in (b)(4). We may place the foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Sally S. Eberhard, Compliance Officer, Division of Southwest Imports, 4040 N. Central Expressway, Ste 300, Dallas, TX 75204. If you have any questions regarding this letter, you may contact Ms. Sally Eberhard via email at Sally.Eberhard@fda.hhs.gov. Please reference CMS # 6094395 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Todd Cato
District Director
Division of Southwest Imports

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