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  5. Manzela USA, LLC - 642268 - 11/07/2022
  1. Warning Letters

WARNING LETTER

Manzela USA, LLC MARCS-CMS 642268 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Andres Venado
Recipient Title
Owner
Manzela USA, LLC

1300 E. Hackberry Ave.
McAllen, TX 78501-5748
United States

Issuing Office:
Division of Southwest Imports

United States

November 7, 2022

WARNING LETTER

Re: CMS # 642268

Dear Mr. Andres Venado:

On June 15, 2022 through June 24, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Manzela USA, LLC located at 1300 E. Hackberry Ave., McAllen, TX 78501. We also conducted an inspection on May 13, 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 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 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 acknowledge receipt of your response dated June 28, 2022, and we address your response below.

In your response, you stated you are currently working to correct the FSVPs you have and to create FSVPs that are missing. We are unable to evaluate the adequacy of your response because you did not provide any supporting documentation or describe specific steps that you have taken to comply with the FSVP regulation. 

Your significant violations of the FSVP regulation are as follows: 

1.  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 the following foods you import:

  • Com Chips imported from foreign supplier Manzela S.A. de C.V., located in Mexico
  • (b)(4) Candy imported from foreign supplier (b)(4) located in (b)(4)
  • Peanuts imported from foreign supplier Manzela S.A. de C.V., located in Mexico

2.  You did not meet the requirement to evaluate your foreign supplier's performance and the risk posed by the food, and to approve your foreign supplier on the basis of this evaluation, in accordance with 21 CPR 1.505. Specifically, during our inspection, you provided a document titled, "Food Safety Plan, Manzela USA," which you described as an FSVP for Haba Enchilada (Fava Bean with Chili Seasoning) imported from Manzela, S.A. De C.V., Mexico. The document includes a general description of your facility, contacts for your food safety team, and what appears to be a food safety plan for your Haba Enchilada, including a hazard analysis and tables summarizing process preventive controls, food allergen preventive controls, and a recall plan. The document also contains incomplete sections titled, "re-analysis of food safety plan," and "signature and date." Although some of the activities in the preventive controls sections of this document appear to be associated with hazards identified in the hazard analysis, there is no description or explanation as to who or which entity will conduct these activities, e.g., the importer or the foreign supplier. Furthermore, there is no description of how the information in this document relates to your foreign supplier's performance, including procedures, processes, and practices related to the safety of the food; or applicable food safety regulations and information relevant to the foreign supplier's compliance with those regulations. The document does not include your evaluation of the foreign supplier's performance and the risk posed by the food, as required by 1.505(a), or approval of the foreign supplier, as required by 1.505(b).

3.  You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506 for the products you import. Specifically, you did not document your determination or performance of appropriate supplier verification activities for your Haba Enchilada imported from Manzela S.A. de C.V., located in Mexico. While you provided a document titled, "Food Safety Plan, Manzela USA," which you described as an FSVP for Haba Enchilada, the document does not include information related to your determination of appropriate verification activities or verification activities that you conducted or reviewed. Furthermore, you did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not document your determination of the appropriate supplier verification activity in accordance with 21 CFR 1.506(d). Your written response dated June 28, 2022 did not provide any additional documentation related to your foreign supplier, Manzela S.A. de C.V.

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, subpru.1 L. 

(b)(3)(A)

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law. 

(b)(3)(A)

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. 38l(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)). 

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 revised 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: Emmanuel Dominguez, Compliance Officer, Division of Southwest Imports, 216 W. Village Blvd., Suite 107, Laredo, TX 78041. If you have any questions regarding this letter, you may contact Emmanuel Dominguez via email at Emmanuel.Dominguez@fda.hhs.gov. Please reference CMS # 642268 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 Street, Suite 7200
Dallas, TX 75202

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