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WARNING LETTER

Sunrise Distributors Inc MARCS-CMS 599020 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Farhan Karim
Recipient Title
Vice President
Sunrise Distributors Inc

2411 United Lane
Elk Grove Village, IL 60007
United States

Issuing Office:
Division of Northern Border Imports

United States


February 11, 2020

WARNING LETTER

Re: CMS # 599020


Dear Mr. Farhan Karim:

On December 5, 2019, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) follow-up inspection at Sunrise Distributors Inc., 2411 United Lane, Elk Grove Village, IL 60007-6818. We also conducted an initial inspection on July 9, 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-safety-modernization-act-fsma/fsma-final-ruleforeign-supplier-verification-proqrams-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 your FSVPs for (b)(4) imported from (b)(4); fried onions imported from (b)(4); and basmati rice imported from (b)(4). Your firm did not have FSVPs for these products. 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 9, 2018, and the follow-up inspection on December 5, 2019, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We have not received your response to either Form FDA 483a. Although you indicated in an email dated January 16, 2020 that you were working on a response, FDA has not yet received one.

Your significant violations of the FSVP regulation are as follows:

You did not develop, maintain, and follow an FSVP as required by the section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, your firm did not develop an FSVP for each of the following foods:

(b)(4) manufactured by (b)(4) (e.g., entry# BQT-0252156-3).
• Fried onions manufactured by (b)(4) (e.g., entry# BQT-0252677-8).
• Basmati rice manufactured by (b)(4) (e.g., entry# BQT-0251990-6).

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.

You should take prompt action to correct the above violations. If you do not promptly correct them, 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 (b)(4) manufactured by (b)(4) located in (b)(4); fried onions manufactured by (b)(4) located in (b)(4); and basmati rice manufactured by (b)(4) located in (b)(4). We may place the foods 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.

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 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: Dean Rugnetta, Compliance Officer, FDA Division of Northern Border Imports, 600 Main St. Buffalo, NY 14202. If you have any questions regarding this letter, you may contact Dean Rugnetta via email at dean.rugnetta@fda.hhs.gov. Please reference CMS # 599020 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

cc: Mr. Yousef Karim, President
(b)(6)
sunrise.distributors@hotmail.com

 
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