- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameKayode Ogunjimi
- Africana Market LLC
1649 Montgomery Rd Ste 5
Aurora, IL 60504-4363
- Issuing Office:
- Division of Northern Border Imports
April 29, 2021
Re: CMS # 614057
Dear Mr. Ogunjimi:
From February 9 to March 11, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection for Africana Market LLC located at 1649 Montgomery Rd Ste 5, Aurora IL. 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/foodfood-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During our inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your Egusi Seed Paste, Instant Noodles, and Ogbono Nut Meal imported from (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 FSVP inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. As of the date of this letter, we have not received your response to the Form FDA 483a.
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, maintain, and follow an FSVP for your Egusi Seed Paste, Instant Noodles, and Ogbono Nut Meal imported from (b)(4).
On February 27, 2021, you emailed our investigator a single lab analysis report for “(b)(4) EGUSI,” for “(b)(4) OGBONO,” and for “(b)(4) INSTANT NOODLES.” You did not provide an explanation of these documents, describe how they would apply to your FSVP program, state that they constitute your FSVP program, or provide a record of your review of these documents. These documents alone do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).
We note that you (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. Failure to adequately address this matter may result in 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 Egusi Seed Paste, Instant Noodles, and Ogbono Nut Meal you import from (b)(4). We may place the foods you import from the identified foreign supplier 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 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.
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 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply or any questions to Food and Drug Administration, Attention: Erica Koory, Compliance Officer, FDA Division of Northern Border Imports, at firstname.lastname@example.org. Please reference CMS # 614057 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