FDA Issues Warning Letter to Importer After Remote Inspection Finds No FSVP

FDA issued a Warning Letter to EM Advisors LLC / Shop & Save Market of  Niles, IL after a remote FSVP inspection which found the firm had not developed or implemented a FSVP for imported
Bread Mix, Dough Bread Mix and Farmer’s Cheese..

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nem-advisors-llc-shop-save-market-613666-04152021
NEM Advisors LLC / Shop & Save Market
MARCS-CMS 613666 — APRIL 15, 2021

Recipient:
Eva Jakubowski and Cezary Jakubowski
NEM Advisors LLC / Shop & Save Market
9217 N. Greenwood Ave
Niles, IL 60714
United States

Issuing Office:
Division of Northern Border Imports
United States

April 15, 2021

WARNING LETTER
Re: CMS # 613666

Dear Eva Jakubowski and Cezary Jakubowski;

From January 21, 2021 through January 26, 2021 the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection for NEM Advisors LLC / Shop & Save Market located at 9217 N. Greenwood Ave., Niles, IL. 60714. We also conducted an inspection on July 29, 2019. 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 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 any of the foods you import from your foreign suppliers, including Bread Mix imported from (b)(4), Dough Bread Mix imported from (b)(4) and Farmer’s Cheese imported from (b)(4). You did not have FSVP’s for these foods or any of 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 both the initial FSVP inspection on July 29, 2019 and the follow up inspection on January 26, 2021, our investigator provided you with Form FDA 483a, FSVP Observations.

We acknowledge receipt of your email dated March 4, 2021 providing FSVP training certificates of completion for three individuals; however, you did not provide context as to who these individuals are, nor did you provide FSVPs for any of the foods you import.

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 but not limited to, the following foods:

Bread Mix imported from (b)(4), located in (b)(4).

Dough Bread Mix imported from (b)(4), located in (b)(4).

Farmer’s Cheese imported from (b)(4), located in (b)(4).

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 provide 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 food products you import. We may place the 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, “Detention Without Physical Examination of Human and Animal Foods Imported from the Foreign Suppliers by Importers Who Are Not in Compliance with the requirements of the Foreign Supplier Verification Program (FSVP) Regulation,” 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.

In addition to the above violations, we also have the following comments:

The Farmer’s Cheese that you import from (b)(4) in (b)(4) appears to be a ready-to-eat product. Based on the hazard analysis we conducted of the ready-to-eat Farmer’s Cheese, it appears to be a product for which there is a reasonable probability of serious adverse health consequences or death to humans or animals (SAHCODHA), and the microbiological hazards are: Salmonella; pathogenic E. coli; L. monocytogenes, S. aureus and Clostridium botulinum.

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 email your reply to Food and Drug Administration, Attention: Julie Scoma, Compliance Officer, Division of Northern Border Imports, at Julie.Scoma@fda.hhs.gov. Please reference CMS # 613666 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