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  5. ARYZ Trading LLC - 639322 - 09/21/2022
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WARNING LETTER

ARYZ Trading LLC MARCS-CMS 639322 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Rida H. Khalife
Recipient Title
Owner
ARYZ Trading LLC

6470 Miller Rd.
Dearborn, MI 48126
United States

Issuing Office:
Division of Northern Border Imports

United States

September 21, 2022

WARNING LETTER

Re: CMS #639322

Dear Rida Khalife:

On June 29th through July 13th, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of ARYZ Trading, LLC located at 6470 Miller Rd., Dearborn, MI 48126. This inspection was 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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion this 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 July 13th, 2022.

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 any of the foods you import, including each of the following foods:

  • Dried mint: imported from (b)(4)
  • Tahina: imported from (b)(4)
  • Extra virgin olive oil: imported from (b)(4)

During our inspection, our investigator explained the FSVP regulation generally requires that you conduct a written hazard analysis (21 CFR 1.504), evaluate your foreign supplier’s performance (21 CFR 1.505), and conduct foreign supplier verification activities (21 CFR 1.506). Our investigator also explained that you must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce 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 and the implementing regulations, or produces food that is adulterated under section 402 of the FD&C Act, as required per 21 CFR 1.508(a). In relation, our investigator informed you that FDA analyzed a sample of dried mint collected on 3/30/2022 from a shipment you imported on 3/15/2022, detected Salmonella and determined the dried mint was adulterated under section 402 of the FD&C Act. Our investigator also told you that FDA analyzed a sample of your extra virgin olive oil collected on 5/20/2022 from a shipment you imported on 3/23/2022 and detected a pesticide chemical residue, which causes the article to be adulterated under section 402(a)(2)(B) of the FD&C Act. Further, since our inspection, FDA analyzed a sample of sesame seeds collected on 7/19/2022 from a shipment you imported on 05/24/2022, detected Salmonella and determined the sesame seeds were adulterated under section 402 of the FD&C Act.

Per the general FSVP requirements mentioned above, in evaluating your foreign supplier’s performance per 21 CFR 1.505, you must consider applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety, per 1.505(a)(1)(iii)(B). We further note that your foreign supplier, (b)(4), located in (b)(4), is listed on the red list of import alert 99-19, Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella for both sesame seeds and dried mint, and your foreign supplier, (b)(4), located in (b)(4), is listed on import alert 99-08, Detention without Physical Examination of Processed Human and Animal Foods for Pesticides for extra virgin olive oil.

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 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: Erica Koory, Compliance Officer, Division of Northern Border Imports, at erica.koory@fda.hhs.gov. If you have any questions regarding this letter, you may contact CO Koory via email. Please reference CMS #639322 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 J. Jasukaitis
Program Division Director
Division of Northern Border Imports

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