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WARNING LETTER

Sahara Enterprise Inc. MARCS-CMS 728927 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Khalid A. Zaidan
Recipient Title
Owner
Sahara Enterprise Inc.

10981 Decatur Rd. Ste 4
Philadelphia, PA 19154-3213
United States

FBOUKHORB@GMAIL.COM
Issuing Office:
Office of Inspections and Investigations

United States

April 29, 2026

WARNING LETTER

RE: CMS# 728927

Dear Khalid A. Zaidan:

On February 27,2026 through March 16,2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Sahara Enterprise Inc. located at 10981 Decatur Rd., Ste 4, Philadelphia, PA 19154-3213. We also conducted an inspection on November 15, 2018, December 28, 2020, July 28,2022 and September 14,2023. 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 these significant violations, 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.

We acknowledge receipt of your response, dated April 07,2026 in which you stated that you will try to learn more on how to prepare FSVP records and also try to get third-party help and prepare FSVP records for the three products. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions. To date, no additional FSVP documents have been received by FDA.

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 each of the following foods:

1. DRY DOUGH MIX (phyllo dough) imported from (b)(4), located in (b)(4).
2. CANDY (Turkish delight) imported from (b)(4), located in (b)(4).
3. BAKLAVA imported from (b)(4) located in (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 with 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 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 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 send your reply to Food and Drug Administration, Attention: Jananiga Vanniyasingam, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy) Jananiga.vanniyasingam@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Vanniyasingam via email at Jananiga.vanniyasingam@fda.hhs.gov. Please reference CMS # 728927 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

CDR Joseph S. Tomao
Program Division Director
Division of Northeast Imports

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