WARNING LETTER
Euphrates Foods, LLC dba Labeeb Alani Inc.
MARCS-CMS 618723 —
December 23, 2021
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Labeeb Bahjat Hasan
Recipient Title
President
Euphrates Foods, LLC dba Labeeb Alani Inc.
9444 Oliphant Ave.
Morton Grove
,
IL
60053-1048
United States
Issuing Office:
Division of Northern Border Imports
United States
December 23, 2021
WARNING LETTER
CMS # 618723
Dear Mr. Hasan:
On September 7 through September 27, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Euphrates Foods, LLC dba Labeeb Alani Inc., located at 2240 Landmeier Rd. Elk Grove Village, IL. We also conducted an inspection on March 11 through March 15, 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 inspection, our investigator provided you with a Form FDA 483a, FSVP Observations on September 27, 2021. We acknowledge receipt of your emailed response dated October 11, 2021, and we address your response below.
In your response, you acknowledged you do not have FSVP records. You also stated you plan on taking the [FSVP] course and submitting FSVPs for the foods you import after 8 to 12 months. However, we note that this is the second inspection in which you did not have any FSVP records, and you did not provide any documentation of the activities that you are taking in order to comply.
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) for the foods you import, including the following foods:
Roasted white pumpkin seeds and nuts in-shell imported from
(b)(4)
Pistachio toffee imported from
(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. If you do not adequately address this matter, we may take 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 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 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 working 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 #618723 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
Content current as of:
03/15/2022
Regulated Product(s)
Food & Beverages