Delivery Method: Via Express Delivery Product: Food & Beverages

Recipient:

Recipient Name

Cesar Mena

Mena Produce LLC

2501 W Military Hwy, Suite E6
McAllen, TX 78503-8952
United States

Issuing Office: Division of Southwest Imports

United States


September 20, 2022

WARNING LETTER

Re: CMS # 637641

Dear Mr. Mena,

On June 14 through June 21, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Mena Produce LLC, located at 2501 W Military Hwy, Suite E6, McAllen, TX 78503. We also conducted an inspection on October 16, 2020 through October 21, 2020. 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 Foreign Supplier Verification Program (FSVP) implementing 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 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 most recent inspection, our investigator provided you with Form FDA 483a, FSVP Observations. We received your response in a letter dated July 15, 2022, attached to an email from your consultant, (b)(4) at (b)(4). Your response stated that you have not developed an FSVP because you were focused on having your facility and organization certified in (b)(4). You stated that you hired a food safety consultant to assist develop your FSVP programs which may take a minimum of 3-4 months for the products covered during the current inspection; Anaheim Pepper, Tomatillo, and Poblano Peppers, and 9-12 months for all or most imported foods, starting as of August 2022. We are unable to evaluate the adequacy of your response because, you did not provide any records or, other than hiring a consultant, describe specific steps you will take to comply with the FSVP regulation.

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, maintain, and follow an FSVP for any of the foods you import, including each of the following:

  • Anaheim peppers imported from (b)(4), located in (b)(4)
  • Tomatillos imported from (b)(4), located in (b)(4)
  • Poblano peppers imported from (b)(4), located in (b)(4)

You import fresh produce, which 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 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: Zumera Ajani, Compliance Officer, Division of Southwest Imports, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have any questions regarding this any letter, you may contact Compliance Officer Zumera Ajani via email at [email protected] Please reference CMS # 637641 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:
Mena Produce LLC
2501 W Military Hwy, Suite E6
McAllen, TX 78503-8952