Lux Commercial Group LLC

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May 18, 2021

WARNING LETTER

Re: CMS # 614025

Dear Mr. Rodriguez,

From March 2-3, 2021, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of records that you were asked to submit to FDA. We also conducted an initial inspection on March 4, 2019. 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 food products you import including, but not limited to, (b)(4) Mango Drink imported from foreign supplier (b)(4), located in (b)(4); (b)(4) Corn Chips imported from (b)(4), located in (b)(4); and Corn Flour imported from foreign supplier (b)(4), located in (b)(4). You did not have FSVPs for these foods or for any other food product you import. 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 in March 2019 and the follow-up inspection in March 2021, our investigator provided you with a Form FDA 483a, FSVP Observations. To date, we have not received a written response to either Form FDA 483a.

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 food products you import, including:

• (b)(4) Mango Drink imported from (b)(4), located in (b)(4)
• (b)(4) Corn Chips imported from (b)(4), located in (b)(4)
• Corn Flour 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.

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 food products 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 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 revised 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: Attention: Kendra J. Vieira, Compliance Officer, 2320 Paseo de las Americas, Suite 200, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Kendra J Vieira via email at Kendra.Vieira@fda.hhs.gov. Please reference CMS # 614025 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/

Todd Cato
Program Division Director
Division of Southwest Imports

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Dear Mr. Rodriguez,

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter Ref: CMS 614025 dated May 18, 2021. Based on our evaluation of the most recent follow-up inspection, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Kendra J. Tunney
Compliance Officer
Division of Southwest Imports