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WARNING LETTER

Re: CMS # 644551

Dear Mr. Paul Chen:

On August 25, 2022 through September 19, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Ruth Special Food Store LLC. located at 95 Washington Ave., Belleville, NJ 07109. We also conducted an inspection on May 28, 2021, through July 27, 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 current inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a that we sent to you on September 19, 2022.

Your significant violation of the FSVP regulation is as follows:

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

• Organic shine skin pumpkin kernels, imported from (b)(4), located in (b)(4)
• Shine skin pumpkin kernels, imported from (b)(4), located in (b)(4)
• Dry roasted edamame, imported from (b)(4), located in (b)(4)

During our inspection, you stated you have not developed FSVPs for any of the foods you import. You also requested your suppliers provide their FSVP documents directly to FDA via email. On August 26, 2022, and September 7, 2022, our investigator received emails, which you also received as you were copied, with documents provided by your suppliers. The email from (b)(4), included a Cleaning Validation Procedure, Certificate of Analysis, Environment Monitor Control Program, Ethical Sourcing Procedure, Food Safety and Defense Plan, and three (b)(4) Analytical Reports from March 2022. The email from (b)(4), included an Inspection Certificate of Quality by Entry-Exit Inspection and Quarantine of (b)(4) and three (b)(4) Analytical Reports from May 2022. Although these documents could be relevant to development of an FSVP, you did not provide a record of your review of the relevant documents or explain how they would apply to your FSVP program. Thus, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).

The above violation is 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 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 FSVPs, 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: David Trent-Carlson, Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLRESPONSES@fda.hhs.gov. Please also cc (carbon copy) David.Trent-Carlson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at David.Trent-Carlson@fda.hhs.gov. Please reference CMS # 644551 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Theresa Smedley
Acting Program Division Director
Division of Northeast Imports