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WARNING LETTER

J&R Produce, Inc. MARCS-CMS 680830 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Rodolfo Perez
Recipient Title
Owner
J&R Produce, Inc.

528 W 28th St
Houston, TX 77008-1914
United States

Issuing Office:
Division of Southwest Imports

United States


May 28, 2024

WARNING LETTER
 

Re: CMS # 680830

Dear Mr. Perez:

On March 13 through 14, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of J&R Produce, Inc. located at 528 W 28th St, Houston, TX 77008-1914. We also conducted inspections on August 26, 2020, August 18, 2022, and February 17, 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- foreignsupplier-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 have not received your response to the Form FDA 483a issued on March 14, 2024.

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 foods that you import, including the following foods:

  • Serrano Pepper, Husk Tomato, and Jalapeno Pepper from (b)(4), located in (b)(4)

During our inspection you provided an audit certificate for (b)(4), which is described as a packing house operation on the audit certificate. Per 21 CFR 1.500, a foreign supplier of an article of food is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature. Based on the documents you provided to FDA, your foreign supplier of the serrano peppers, husk tomato, and jalapeno peppers is (b)(4), located in (b)(4). However, you did not provide any FSVP documents that apply to your foreign supplier, as required by 21 CFR 1.502(a).

You import fresh produce that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least 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).

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 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)).

Additionally, we offer the following comment:

During our previous FSVP inspection on February 17, 2023, you provided FSVP documents including hazard analyses, evaluation of foreign supplier performance and approval, and 3rd party audit certificates for serrano peppers, husk tomato, and jalapeno peppers from (b)(4) who we understand to be a packing house and not your foreign supplier. An establishment that only packs or holds food is not a foreign supplier per 21 CFR 1.500. However, the records you provided may be used to assist you with complying with the FSVP regulation, such as when making a determination of appropriate foreign supplier verification activities per 21 CFR 1.506(d). Such verification activities must address the entity or entities that are significantly minimizing or preventing the hazards or verifying that the hazards have been significantly minimized or prevented (e.g., when an entity other than the grower of produce subject to 21 CFR part 112 harvests or packs the produce and significantly minimizes or prevents the hazard or verifies that the hazard has been significantly minimized or prevented), per 21 CFR 1.506(d)(1)(i).

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 # 680830 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Alexander Lopez
Acting Southwest Imports Program Director
1201 Main Street
Suite 7200
Dallas, TX 75202

 
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