---

---

---

August 3, 2021

WARNING LETTER

Re: CMS # 614241

Dear Mr. Tamez:

On March 11 through March 16, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Productos Bredy USA LLC located at 7601 North Loop East, Houston, TX 77028-6017. We also conducted an initial inspection on September 24, 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 inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for the foods you import, including your FSVP for (b)(4) Soft Drinks from supplier (b)(4), located in (b)(4). You did not develop an FSVP for this product, nor any of the products 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.

While you registered to complete training on FSVP and committed to developing FSVPs at the conclusion of the inspection in 2018, you have not developed an FSVP for any of the products you import. We also have not received a response to the Form FDA 483a issued on March 16, 2021.

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 your (b)(4) Soft Drinks imported from (b)(4), located in (b)(4).

(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 (b)(4) Soft Drink from supplier (b)(4), located in (b)(4), as well as the other products you import for which you appear to be in violation of Section 805. We may place the foods you import 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 these violations. You should include in your response documentation and information that will 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 the foods you import 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: Melissa G. Gonzalez, Compliance Officer, the Division of Southwest Imports, 1201 Main Street Suite 7200, Dallas, TX 75202. If you have any questions regarding this letter, you may contact Melissa G. Gonzalez via email at melissag.gonzalez@fda.hhs.gov. Please reference CMS # 614241 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