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WARNING LETTER

Regino Produce LLC MARCS-CMS 632384 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Reginaldo (NMI) Rodriguez
Recipient Title
Owner
Regino Produce LLC

1842 Angeline St.
Houston, TX 77009-1250
United States

Issuing Office:
Division of Southwest Imports

United States


WARNING LETTER

June 27, 2022

Re: CMS # 632384

Dear Mr. Rodriguez:

On April 5 and 11, 2022, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Regino Produce, LLC located at 1842 Angeline St., Houston, TX 77009-1250. We also conducted inspections on April 24, 2018, and September 30, 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 Fried RTE Corn Chips imported from (b)(4), located in (b)(4), Fresh Raw Serrano Peppers, imported from (b)(4), located in (b)(4) and Fresh Raw Lettuce imported from (b)(4), located in (b)(4). You did not have FSVPs for these products or for most 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 emailed response dated April 26, 2022. Your response to the Form FDA 483a requested an additional four months to develop FSVPs. However, we are unable to evaluate the adequacy of your response as you did not provide any written procedures or documentation of your FSVP activities to show you have made corrections or developed FSVPs for the foods you import. We also note that the most recent inspection was the third FSVP inspection of your firm in which you did not have FSVPs for the majority of the 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 part 1.502(a). Specifically, you stated you did not develop an FSVP for 85 of the 88 foods you import, including:

  • Fried Read-to-Eat Corn Chips imported from (b)(4), located in (b)(4)
  • Fresh Raw Serrano Peppers imported from (b)(4), located in (b)(4)
  • Fresh Raw Lettuce 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. 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 from the identified foreign suppliers 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)).

Additionally, we offer the following comment:

You import serrano peppers, lettuce, and other raw agricultural commodities, which are “covered produce” as defined in 21 CFR 112.3. Your FSVP must provide adequate assurance that the processes and procedures that your supplier uses provide the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. § 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).

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: Lisa Puttonen, Compliance Officer, Division of Southwest Imports, One Main Place, 1201 Main St, Suite 7200, Dallas, Texas 75202. If you have any questions regarding this letter, you may contact Lisa Puttonen via email at lisa.puttonen@fda.hhs.gov. Please reference CMS # 632384 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Todd Cato
Director, Southwest Imports
One Main Place
1201 Main St., Suite 7200
Dallas, Texas 75202

 
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