- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameNaveed Rasool
- MnM Spices Corporation
1010 W. Fullerton Ave., Ste. H
Addison, IL 60101-4333
- Issuing Office:
- Division of Northern Border Imports
Re: CMS # 613884
Dear Mr. Naveed Rasool:
On February 19-22, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for MnM Spices Corporation located at 1010 W. Fullerton Ave., Ste. H, Addison, IL 60101. We also conducted an inspection on August 20 and 23, 2018. 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/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 food products you import, including Steam Rice (Plain), Dates, and Pine Nuts (Shelled) from foreign supplier (b)(4), located in (b)(4). You did not have an FSVP for these products or any food products that you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on August 23, 2018 and the current inspection on February 22, 2021, our investigator provided you with the Form FDA 483a, FSVP Observations, for not developing an FSVP for the foods you import. We acknowledge receipt of your email response, dated February 23, 2021, to the Form FDA 483a issued on February 22, 2021. You state in your response, “As we told the investigator officer, that we don’t have FSVP for any item list it, however we’ll try to get FSVP for the items that are list as soon as we can. We hope to FSVP for all the items within 1-2 years.” However, we found your response inadequate, as you have not made any corrections or developed FSVPs for the food products you import since our initial inspection in August 2018. Further, you have not provided specific steps or actions you have taken or plan to take to come into compliance with the FSVP regulation.
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 any foods that you import, including Steam Rice (Plain), Dates, and Pine Nuts (Shelled) imported from (b)(4), located in (b)(4).
Based on your (b)(4), (b)(3)(A)
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
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. Failure to address this matter adequately may lead to regulatory 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, including Steam Rice (Plain), Dates, and Pine Nuts (Shelled) from your foreign supplier (b)(4), located in (b)(4), that appear to be in violation of section 805. We may place these foods you import on detention without physical examination (DWPE) when you import the products.
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.
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 address 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 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please email your reply to the Food and Drug Administration, Attention: Erica Koory, Compliance Officer, Division of Northern Border Imports, at firstname.lastname@example.org. Please reference CMS # 613884 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports