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WARNING LETTER

Mina Global Trading Corp MARCS-CMS 636140 —


Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
John Gharghoury
Recipient Title
Owner
Mina Global Trading Corp

53 Idaho Ln
Matawan, NJ 07747-1530
United States

Issuing Office:
Division of Northeast Imports

United States


August 8, 2022

WARNING LETTER

RE: CMS # 636140

Dear Mr. John Gharghoury:

On April 22 through May 10, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Mina Global Trading Corp, located at 53 Idaho Ln, Matawan, NJ 07747-1530. We also conducted an inspection on April 12 through April 19, 2021. 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 you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspections, our investigator provided you with a Form FDA 483a, FSVP Observations.

During our inspection, you indicated you choose to comply with the requirements for very small importers, and you provided our investigator documentation that you meet the definition of very small importer in 21 CFR 1.500. As a very small importer, you are required to comply with the requirements in sections 1.502, 1.503, 1.509, and 1.512, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. 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)).

We have not received your response to the Form FDA 483a issued on May 10, 2022.

Your significant violations of the FSVP regulation are as follows:

As a very small importer, for each food you import, you did not obtain written assurance in accordance with 21 CFR 1.512(b)(3), 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. During our inspection you told our investigator you did not have FSVP documents, including written assurances, for any of the food products you import, including your wafers with chocolate and sesame bars from (b)(4), located in (b)(4) and feta cheese from (b)(4), located in (b)(4).

You may find information on documenting your eligibility as a very small importer and the other requirements under 21 CFR 1.512 in the “Draft Guidance for Industry Foreign Supplier Verification Programs for Imports of Food for Human and Animals” at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals

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 https://www.accessdata.fda.gov/cmsia/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 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 address any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Russell Vandermark, FDA Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Russell.Vandermark@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Vandermark via email at Russell.Vandermark@fda.hhs.gov. Please reference CMS # 636140 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/

Anna Alexander
Acting Program Division Director
Division of Northeast Imports

 
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