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  5. Sobh Import, Inc. - 614391 - 06/08/2021
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WARNING LETTER

Sobh Import, Inc. MARCS-CMS 614391 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Wally M. Sobh
Sobh Import, Inc.

14344 W. Warren Ave.
Dearborn, MI 48126-1459
United States

Issuing Office:
Division of Northern Border Imports

United States

June 8, 2021

WARNING LETTER

Re: CMS # 614391

Dear Mr. Sobh:

On March 22 through 29, 2021, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection for Sobh Imports, Inc. located at 14344 W. Warren Ave., Dearborn MI. We also conducted an inspection on November 6, 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 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-safetymodernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During our most recent inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for any products you import, including your Lokum Biscuit imported (b)(4) For (b)(4), your Sugar-Coated Pistachios imported (b)(4), and your Nougat with Cardamon imported from (b)(4). You did not have FSVPs for these food products or for any other food product imported by your firm. 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 November 6, 2018 and the follow-up inspection on March 29, 2021, our investigator provided you in each instance with a Form FDA 483a FSVP Observations.

We acknowledge receipt of your email response dated April 12, 2021 stating, “In the next (b)(4) we will be attending a FSVP class upon finding and enrolling in a class and will (b)(4); decide on (b)(4); and implementing the new things we will learn from the FSVP course and begin applying the regulation according to (b)(4).”

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 the following foods:

o Lokum Biscuit manufactured by (b)(4),
o Sugar Coated Pistachio manufactured by (b)(4), and
o Nougat with Cardamon manufactured by (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 food products you import that appear to be in violation of section 805. We may place the foods you import from the identified foreign suppliers 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 (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 will 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 to Food and Drug Administration, Attention: Mark Kaspar, Compliance Officer, DNBI, USFDA, 550 W Jackson, 15th Floor Chicago IL 60661. If you have any questions regarding this letter, you may contact Mark Kaspar via email at mark.kaspar@fda.hhs.gov. Please reference CMS # 614391 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

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