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December 18, 2023

WARNING LETTER

Re: CMS # 670651

Dear Mr. Jose Leiva:

On October 12 through October 13, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of A True Move LLC located at 923 Crosstimbers St # 917, Houston, TX 77022. We also conducted previous inspections last August 16 through August 17, 2017 and on April 19 through April 21, 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 November 2, 2023, where you indicated your consultation with (b)(4), and you provided a letter from them. The letter confirmed that on May 17, 2023, five months before our inspection, you began utilizing their services to “consistently monitor” your foreign suppliers and “for 3 FSVP plans to be written.” We are unable to evaluate the adequacy of your response because, other than the letter described above, you have not provided any supporting documentation demonstrating your planned or completed corrective actions, including providing documentation or a timeframe when to expect the completion of your FSVP plans. To date, no additional FSVP documents have been received by FDA.

Your significant violations of the FSVP regulation are as follows:

1. 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 the following foods:

• Banana Sodas imported from (b)(4), located in (b)(4)
• Lollipops imported from (b)(4), located in (b)(4)
• Tomato Paste 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.

In addition, FDA has determined that (b)(3)(A).

As a responsible official of a facility that manufacturers/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.

We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at https://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).

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 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: Emmanuel Dominguez, Compliance Officer, Division of Southwest Imports, 216 W. Village Blvd., Suite 107, Laredo, TX 78041. If you have any questions regarding this letter, you may contact Emmanuel Dominguez via email at Emmanuel.Dominguez@fda.hhs.gov. Please reference CMS # 670651 on any documents or records you provide to us and within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Todd Cato
Director, Southwest Imports
One Main Place
1201 Main Street, Suite 7200
Dallas, TX 75202