Moda Food LLC

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WARNING LETTER

Re: CMS # 727800

Dear Mr. Rubil Vural,

On March 13 through 18, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Moda Food LLC, located at 4 Andrews Dr, Woodland Park, NJ 07424. We also conducted inspections on December 29, 2022, December 6, 2023, and June 12, 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 foods from the foreign suppliers indicated in the attached list, as well as your Phyllo imported from (b)(4), your Baklava (Double Pistachio) imported from (b)(4), and your Tahini Halva imported from (b)(4), all located in (b)(4). 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 have not received your response to the Form FDA 483a issued on March 18, 2026.

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 the foods you import from the foreign suppliers indicated in the attached list.

During the inspection, you stated that the foods for which you had no FSVPs were samples for food shows and for research and development. Pursuant to 21 CFR 1.501(c), food imported for research or evaluation is exempt from the FSVP requirements provided that it is: (1) not intended for retail sale and is not sold or distributed to the public, (2) labeled with the statement “Food for research or evaluation use,” (3) imported in a small quantity that is consistent with a research, analysis, or quality assurance purpose, the food is used only for this purpose, and any unused quantity is properly disposed of, and (4) accompanied, when filing entry with U.S. Customs and Border Protection, by an electronic declaration that the food will be used for research or evaluation purposes and will not be sold or distributed to the public. You did not provide any documentation for any of these imported products that demonstrated that they met any of the criteria for an exemption for food imported for research or evaluation under 21 CFR 1.501(c). We note that, based on information available to FDA, some of the foods were not imported in a small quantity that is consistent with a research, analysis, or quality assurance purpose (see 21 CFR 1.501(c)(3)).

2. You did not meet the requirements to perform foreign supplier verification activities as required by 21 CFR 1.506. Specifically, for your Phyllo imported by (b)(4), Baklava (Double Pistachio) imported by (b)(4), and your Tahini Halva imported by (b)(4), you did not determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the foods you obtain from these foreign suppliers are produced in accordance with 21 CFR 1.506(c), as required by 1.506(d). Furthermore, you did not document or obtain documentation of one or more supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each of these foreign suppliers before importing the foods and periodically thereafter, as required by 21 CFR 1.506(e)(1).

Your FSVPs for the foreign suppliers referenced above state that your supplier verifications are conducted through a combination of "documentation review" and "supplier approval procedures". Each FSVP says that the foreign supplier maintains certifications and lists the certification standard(s), indicating that these certifications either confirm or verify that the supplier maintains a "food safety management system." Additionally, you told our investigator during the inspection that your verification activities consist of (b)(4), (b)(3)(A) status. However, as noted above, you did not determine and document the frequency of these activities, as required by 21 CFR 1.506(d). Furthermore, you were unable to provide any documents that you reviewed as part of your supplier verification activities (e.g., certificates, audit reports), or any documentation of your review and assessment of any records of supplier verification activities, as required by 1.506(e)(1). We note that if you conduct a review of the foreign supplier’s relevant food safety records as a foreign supplier verification activity, you must retain documentation of each record review, including the date(s) of review, the general nature of the records reviewed, the conclusions of the review, any corrective actions taken in response to significant deficiencies identified during the review, and documentation that the review was conducted by a qualified individual, as required by 21 CFR 1.506(e)(1)(iii).

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 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 # 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 (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: Tara Carmody, Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Tara.Carmody@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Carmody via email at Tara.Carmody@fda.hhs.gov. Please reference CMS # 727800 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