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WARNING LETTER

Selamta LLC MARCS-CMS 613486 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Ashenafi G. Arega
Recipient Title
Owner
Selamta LLC

735 Park North Blvd
Clarkston, GA 30021-1971
United States

Issuing Office:
Division of Southeast Imports

United States


May 07, 2021

Re: CMS # 613486

Dear Mr. Arega:

On January 27, 2021 through February 3, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of FSVP records that your firm was asked to submit to FDA. We also conducted an initial inspection on November 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-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 your Black Tea imported from (b)(4), located in Ethiopia. Your firm did not have an FSVP for this product 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 the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.

We acknowledge receipt of your response dated February 10, 2021. In your response, you state that “we have not developed an FSVP currently in our company,” but that you plan to implement your FSVP plans within the next four to six months. We also acknowledge that at the closing of the inspection, you stated that you will be working to complete the Food Safety Preventive Controls Alliance (FSPCA) FSVP training to develop your FSVP plan(s), however to date you have not provided an FSVP.

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 your Black Tea imported from (b)(4), located in Ethiopia.

(b)(3)(A)

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. 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 #99-41 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., 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 your products 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: Jason Ferry, Compliance Officer, Division of Southeast Imports, 959 Ridgeway Loop Road, Ste. 100, Memphis, TN 38120. If you have any questions regarding this letter, you may contact Officer Ferry via email at jason.ferry@fda.hhs.gov. Please reference CMS case # 613486 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/

Ruth Dixon
Program Division Director
Division of Southeast Imports

 
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