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  5. Mexia Pallets LLC - 633369 - 08/16/2022
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WARNING LETTER

Mexia Pallets LLC MARCS-CMS 633369 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Laura Mejia de Jalili
Recipient Title
Owner
Mexia Pallets LLC

4403 N Cesar Chavez Rd
San Juan, TX 78589-4081
United States

Issuing Office:
Division of Southwest Imports

United States

August 16, 2022

WARNING LETTER

Re: CMS # 633369

Dear Mrs. Mejia de Jalili:

On April 5, 2022 to April 7, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Mexia Pallets LLC located at 4403 N Cesar Chavez Rd San Juan, Texas. We also conducted an inspection on August 03, 2021 to August 12, 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 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 April 13, 2022, and we address your response below.

In your response, you acknowledged you understand your requirements and asked for three months to gather the required information. However, you did not provide evidence of the steps you have taken or will take to develop an FSVP for the food products you import. Therefore, we are unable to evaluate the adequacy of your response. On May 13, 2022, our compliance officer emailed you asking for an update on your FSVP plan. You replied on the same date with entry documents and no additional information. Furthermore, we note you provided no response to the observations made after the August 2021 inspection.

Your significant violations of the FSVP regulation are as follows:

You did not develop, maintain, and follow a 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 food products you import, including each of the following food products:

  • Persian limes imported from (b)(4), located in (b)(4)
  • Apple soft drink imported from (b)(4), located in (b)(4)
  • Orange soft drink 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.

Additionally, we also offer the following comments:

During our most recent inspection, our investigator noted your firm may qualify as a “very small importer” under 21 CFR 1.500. If you meet the definition, you are still required to follow FSVP requirements. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer on an annual basis as required per 21 CFR 1.512(b)(1)(i).

In addition we note, as a very small importer, for each food you import, you must obtain written assurance, in accordance with 21 CFR 1.512(b)(3), before importing the food and at least every two years thereafter, that your foreign 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 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act. You may find information on documenting your eligibility as a very small importer and the other requirements under 21 CFR 1.512 in the “Draft Guidance for Industry Foreign Supplier Verification Programs for Imports of Food for Human and Animals at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals.

You import fresh produce, Persian Limes from foreign supplier (b)(4) located in (b)(4), which is “covered produce” as defined in 21 CFR 112.3. Your FSVP must demonstrate 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).

You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entry with U.S. Customs and Border Protection, as required by 21 CFR 1.509(a). As the owner or consignee of food that is being offered for import into the United States, you are the importer (see 21 CFR 1.500). However, the entries reviewed during the inspection did not include a valid unique facility identifier. Specifically, you did not provide a DUNS number for shipments of Persian Limes imported in entry (b)(4), Apple Soft Drink imported in entry (b)(4), and Orange Soft Drink imported in entry (b)(4); instead “UNK” was transmitted as the DUNS number. It is your responsibility to ensure that the required information under 21 CFR 1.509(a) is provided at the time of entry.

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)).

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: Alina A. Schmidt, Compliance Officer, 2320 Paseo de las Americas, Suite 200, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Alina A. Schmidt via email at alina.schmidt@fda.hhs.gov. Please reference CMS # 633369 on any documents or records you provide to us and/ or on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Todd Cato
Director, Southwest Imports

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