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January 19, 2023

WARNING LETTER

Re: CMS # 646874

Dear Mr. Nimocks:

On October 24, 2022, through October 28, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Sohgave LLC located at 4500 N Sam Houston Pkwy W Ste 120, Houston, TX 77086. We also conducted an inspection on August 26, 2021, through September 13, 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 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 email response dated November 8, 2022. In your response, you stated you would complete your FSVP “for the products and companies on the attached 483 by November 30, 2022.” On November 16, 2022, our compliance officer emailed you requesting an update on your corrective actions. We have not received any additional response from you. We are unable to evaluate the adequacy of your response because you did not provide documentation demonstrating evidence of the specific steps you have taken to comply with FSVP for the food products you import.

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, maintain, and follow an FSVP for any foods that you import, including the following foods:

• Honey imported from (b)(4) in (b)(4)
• Agave Syrup, honey, coconut syrup and inulin syrup imported from (b)(4) in (b)(4)

During the inspection you stated you do not have an FSVP for any of the foods you import. You provided our investigator documents which included certificates of analysis for your honey and agave syrup. You told our investigator that the certificates of analysis you provided were not associated with an FSVP for these foods. 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 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.

(b)(3)(A)

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

(b)(3)(A)

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 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: Alina A. Schmidt, Compliance Officer, 9777 Via de las Amistad, Suite 131, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Alina A. Schmidt via email at alina.schmidt@fda.hhs.gov. Please reference CMS # 646874 on any documents or records you provide to us and/ or on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Todd Cato
Director, Southwest Imports