Zip Foods Importers, Inc

WARNING LETTER Zip Foods Importers, Inc MARCS-CMS 713379 — January 16, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Leon Nagel Recipient Title Owner/Partner Zip Foods Importers, Inc 160 Raritan Center Pkwy Ste 6 Edison , NJ 08837-3637 United States zipfoodsimporters@gmail.com Issuing Office: Office of Inspections and Investigations United States WARNING LETTER January 16, 2026 RE: CMS# 713379 Dear Mr. Leon Nagel: On June 20 through June 27, 2025, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Zip Foods Importers, Inc located at 160 Raritan Center Pkwy Ste 6, Edison, NJ 08837-3637. We also conducted an inspection on November 18 through 22, 2024. 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 the following foods you import: Millet Seed and Buckwheat, Mushrooms and other fungi products, Cherry Fruit, Mixed Fruit, Frozen Black Currants (Mixed Core), Baked Snack Food, Granola Bars, Plain Cookies, Biscuits, Cheesecake, Cheese Sticks, and Smoked Cheese Sticks. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We acknowledge your response received July 14, and July 30th, 2025, in which you stated that you have updated your FSVP documentation to reflect a change in the manufacturer for Yoghurt Drink Ayran that you import from (b)(4) located in (b)(4) . You also submitted FSVP documentation for some of the products that you import, but none of those which are included in this letter. We are unable to evaluate the adequacy of your response in relation to the products detailed in this letter because you have not provided any supporting documentation demonstrating your corrective actions for the aforementioned foods that you import. To date, no additional FSVP documents have been received by FDA in relation to the foods listed below. Your significant violations of the FSVP regulation are as follows: 1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, you did not develop an FSVP for each of the following foods: Millet Seed and Buckwheat, Whole Grain from the foreign supplier (b)(4) located in (b)(4) . Oyster Mushrooms, Shiitake Mushrooms, and Mushrooms and other fungi products, from the foreign supplier (b)(4) located in (b)(4) . Cherry Fruit, Mixed Fruit, Frozen Black Currants (Mixed Core), Currants – Red (Berry), and Lingonberry (Berry) - Frozen Cowberry from the foreign supplier (b)(4) located in (b)(4) . Baked Snack Food, Granola Bars, Plain Cookies, and Biscuits from the foreign supplier (b)(4) located in (b)(4) . Cheesecake, Cheese Sticks, and Smoked Cheese Sticks from the foreign supplier (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. This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we 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 the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States from the identified foreign suppliers on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # (b)(4) 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 (21 U.S.C. 331(zz)). 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 any 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 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 working 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: Stanley Nelson, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy) Stanley. Nelson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Nelson via email at Stanley.Nelson@fda.hhs.gov. Please reference CMS # 713379 on any documents or records you provide to us and on the subject line of any email correspondence you send to us. Sincerely, /S/ CDR Joseph S. Tomao Program Division Director Division of Northeast Imports Content current as of: 01/27/2026 Regulated Product(s) Food & Beverages