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August 30, 2021

WARNING LETTER

Re: CMS # 615363

Dear Ms. Abeneto and Mr. Abeneto:

On May 5, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Ebenezer International Food, LLC located at 26 Mary St. South Burlington, VT 05403. We also conducted an inspection on February 5, 2020. 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 Foreign Supplier Verification Program (FSVP) implementing 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/GuidanceRegulation/FSMA/ucm361902.htm.

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 you import, including grounded cassava leaves imported from (b)(4), and cut sweet potato leaves and cut sorrel leaves imported (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 the inspection, our investigator provided you with Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a issued on May 5, 2021.

Your significant violation of the FSVP regulation is 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, your firm did not develop an FSVP for each of the following foods:
• Grounded cassava leaves imported from (b)(4);
• Cut sweet potato leaves imported from (b)(4); and
• Cut sorrel leaves imported from (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 products you import. We may place the foods you import into the United States 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 https://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.

In addition to the above violations, we also have the following comments:

Grounded cassava leaves manufactured (b)(4) is currently subject to DWPE per import alert 99-19, as a consequence of being found contaminated with Salmonella, and sorrel leaves manufactured (b)(4) currently subject to DWPE per import alert 99-08, as a consequence of being found to contain illegal pesticides. You can find DWPE information relating to Import Alerts at https://www.accessdata.fda.gov/cms_ia/ialist.html.

We note that, based on your sales volume, you may meet the definition of a “very small importer” under 21 CFR 1.500. If you meet the definition, you are still required to follow FSVP requirements. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i). In addition, for each food you import, you must obtain written assurance, before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).

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 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 email your reply to Food and Drug Administration, Attention: Erica Koory, Compliance Officer, Division of Northern Border Imports, at [email protected]. If you have any questions regarding this letter, you may contact Erica Koory via email at [email protected]. Please reference CMS # 615363 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/
Keith Jasukaitis
Program Division Director
Division of Northern Border Imports