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  5. Paso Real Produce LLC - 691665 - 10/01/2024
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WARNING LETTER

Paso Real Produce LLC MARCS-CMS 691665 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Salvador Pulido Novoa
Recipient Title
Owner/President
Paso Real Produce LLC

1301 W. Capote Central Ave.
Pharr, TX 78577
United States

salvador@pasorealproduce.com
Issuing Office:
Division of Southwest Imports

United States

October 1, 2024

WARNING LETTER

Re:  CMS # 691665

Dear Mr. Pulido,  

On August 9-14, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Paso Real Produce, LLC located at 1301 W. Capote Central Ave., Pharr, TX 78577.  We also conducted inspections on September 10, 2021 and April 4-5, 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-ruleforeign-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 this significant violation, 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 have not received your response to the Form 483a issued on August 14, 2024.

Your significant violation 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, your firm did not develop an FSVP for any of the foods you import, including each of the following:  

  • Avocados imported from (b)(4) located in (b)(4)
  • Limes imported from (b)(4) located in (b)(4)
  • Limes imported from (b)(4) located in (b)(4)
  • Limes imported from (b)(4) located in (b)(4)

This is a repeat observation from the previous inspections conducted on September 10, 2021 and April 4-5, 2023  

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 foods you import which appear to be in violation of section 805. We may place these 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 the Food and Drug Administration, Attention: Rosa Linda Santos, Compliance Officer, Division of Southwest Imports, 1201 Main Street, Suite 7200, Dallas, TX, 75202.  If you have any questions regarding this letter, or wish to provide your response via email, you may contact Rosa Linda Santos at rosa.santos@fda.hhs.gov.   Please reference CMS #691665 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  
1201 Main Street, Suite 7200
Dallas, TX 75202 

Cc: Paso Real Produce LLC        
1301 W. Capote Central Ave.      
Pharr, TX 78577

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