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December 08, 2021

WARNING LETTER

Re: CMS # 618098

Dear Mr. Khatri:

On August 25, 2021 through August 26, 2021 the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of VHRK Food Inc., located at 810 Bonnie Lane, Elk Grove Village, IL. 60007-2223. We also conducted an inspection on January 21, 2021 through February 16, 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 this significant violation, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the most recent inspection, our investigator provided you with a Form FDA 483a, FSVP Observations on August 26, 2021. We acknowledge receipt of your response email dated September 9, 2021, and we address your response below.

In your response to the FDA 483a, you indicated that you have notified all your vendors (b)(4) about the FSVP program, you will obtain all certifications before exporting (b)(4), and you will maintain records. You also indicated that you will register for a FSVP training course and that you will update FDA on your training status. We are unable to evaluate the adequacy of your response because you have not provided any specific documentation regarding your implementation of an FSVP or copies of your FSVPs, and you did not provide a timeline for completing these activities. We will review implementation of your corrective actions at our next inspection.

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 the following foods imported from (b)(4)

• Dry dates powder
• Brown Chori (peas)
• Black pepper
• Sun dried gooseberries

The above violation(s) 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, the FDA 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 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 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 (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 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: Julie Scoma, Compliance Officer, Division of Northern Border Imports, at [email protected]. Please reference CMS #618098 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