- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMohamad Jamal Eddin
Recipient TitleCEO/ Purchasing Partner
- Kareem Mart Inc.
32816 Manor Park Drive
Garden City, MI 48135
- Issuing Office:
- Div ision of Northern Border Imports
May 11, 2021
Re: CMS # 613572
Dear Mohamad Jamal Eddin:
On November 18, 2020, December 21, 2020, and January 20-21, 2021 the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically. 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/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your Hummus with Tahina (Tahini) imported from (b)(4), located in (b)(4); your Halwa with Pistachios and Hummus with Tahina (Tahini), imported from Kareem Mart Inc., located in the (b)(4); your imported Sesame Breadsticks from (b)(4); or for your other imported products on the list of your foreign suppliers provided during our inspection, for which you told our investigator you did not have FSVPs. 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 Form FDA 483a, FSVP Observations.
During our inspection, you also stated 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, and 1.509, 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 acknowledge receipt of your response to the Form FDA 483a dated February 8, 2021, which included a letter stating that you were responding to specific 483a observations. Your letter includes general statements regarding your efforts to comply with the FSVP requirements; however, we were unable to evaluate the adequacy of your response because you did not provide any documentation related to your FSVPs.
Your significant violations of the FSVP regulation are as follows:
1. As a very small importer, for each food you import, you must 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 any FSVP documents, including written assurances, for a number of the food products you import, including your Hummus with Tahina (Tahini) and other products imported from (b)(4). You told us that you had letters of assurance from your (b)(4) located in the (b)(4) located in (b)(4). However, to the extent you intend to rely on these written assurances, neither of these foreign suppliers included information indicating that the food products you are importing are covered by their written assurances. Further, although the written assurances state that the supplier uses processes and procedures to comply with “the preventive control’s requirements in the PC Human Food Rule” and with “current good manufacturing practice,” they do not include assurances that the supplier is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act.
2. You must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food consistent with the assurance provided in accordance with 21 CFR 1.512(b)(3)(i) through (iv). The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of circumstances have been adequately addressed. You must document any corrective actions you take in accordance 21 CFR 1.512(b)(4). During our inspection, you told our investigator that you discontinued importing any products containing sesame seeds from Kareem Mart Inc., Syria after receiving the Notice of Action from FDA dated November 6, 2020, indicating that (b)(4) products from your (b)(4) were found to be adulterated and subject to refusal per 402(a)(1) and 801(a)(3) of the FD&C Act respectively, after they tested positive for Salmonella (also see Import Alerts 99-19 and 99-43). You also stated you believed that the Salmonella was from the sesame seed ingredient in the products. Although you responded verbally to the investigator, you did not document corrective actions taken in response to your determination that the foreign supplier did not produce the food consistent with the assurance provided in accordance with 21 CFR 1.512(b)(3)(1) through (iv)a, as required by 21 CFR 1.512(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, the FDA may act 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 # 99-19, 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 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 revised 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 #613572 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