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WARNING LETTER

Mexpobaja Corporation MARCS-CMS 670016 —


Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Omar A. Ibarra
Recipient Title
President
Mexpobaja Corporation

313 Franklin St.
Oakland, CA 94607-3822
United States

Issuing Office:
Division of West Coast Imports

United States

Secondary Issuing Offices

United States


WARNING LETTER

01/23/2024

Re: CMS # 670016

Dear Mr. Ibarra,

From August 29, 2023 to August 31st, 2023 the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Mexpobaja Corporation located at 313 Franklin St. Oakland, CA 94607-3822. We also conducted an inspection from September 19, 2022 through September 28, 2022 and July 07, 2021 through July 13, 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 On 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 have not received your response to the Form FDA 483a issued on August 31st, 2023.

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 from the foreign suppliers indicated in the attached list.

You did provide FSVP documents for the following foods:

  • Pitahaya (Dragonfruit), imported from (b)(4), located in (b)(4)
  • Pasilla Chili Peppers (Poblano), imported from (b)(4), located in (b)(4)
  • Jalapeno Peppers imported from (b)(4), located in (b)(4)

While you provided our investigator a variety of FSVP documents for these specific foods, including the firm’s written procedures for evaluating and approving foreign suppliers and a food safety questionnaire for foreign suppliers, these documents do not meet the FSVP requirements, as discussed below.

Your supplier verification activities did not provide adequate assurance that the hazards requiring a control in the foods you import have been significantly minimized or prevented, as required by 21 CFR 1.506(c). FDA has determined that the biological hazards in covered produce require a control, and compliance with the requirements in the Produce Safety Rule significantly minimizes or prevents the biological hazards. However, your supplier verification activities did not include verifying your suppliers’ compliance with the Produce Safety Rule or documenting processes or procedures that provide at least the same level of public health protection as required by the Produce Safety Rule.

Specifically, your FSVPs for Pitahaya (Dragonfruit), from (b)(4), Pasilla Peppers (Poblano), from (b)(4), and Jalapeno Peppers, from (b)(4) include “Table D4”, “Table C4”, and “Table B4” respectively. Each of these three tables includes the column labeled “Description of Supplier Controls” under which the specific supplier controls are described as “On-site Audit of the packinghouse facilities” and “Letter of Continuing Guarantee and food safety questionnaire.” The tables indicate these verification activities are conducted with a frequency of “Annually.” Based on your description of these records to our investigator, “Table D4", “Table C4”, and “Table B4” in their respective FSVPs, describe your verification activities. The records you provided to demonstrate your verification activities for these foods and suppliers include:

  • Letter of Continuing Guarantee
  • Food Safety Questionnaire for Foreign Suppliers (which are not in English)
  • Chemical analysis results for Pasilla Chili Pepper (Poblano) from (b)(4), and Pitahaya (Dragonfruit) from (b)(4)
  • Chemical and microbiological analysis results for Jalapeno Peppers from (b)(4) (which are not in English)

These records do not indicate whether you verified your supplier’s compliance with the Produce Safety Rule. In addition, you did not demonstrate the standards on which the letters of guarantee or food safety questionnaire, or onsite audits, which you did not provide record of, provide at least the same level of public health protection provided by the Produce Safety Rule.

Pitahaya (Dragonfruit), Pasilla Peppers (Poblano), Jalapeno Peppers, and other fresh produce that you import are “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).

An importer may import food consistent with the FSVP regulation even if their foreign supplier uses processes or procedures that vary in some way from the processes and procedures required under the applicable requirements in these regulations, provided that the importer follows an FSVP that provides adequate assurance that the processes and procedures that the supplier uses provide the same level of public health protection as those required under the specified FDA requirement. However, you did not provide details of your evaluation that concluded that your supplier’s processes and procedures provided the same level of public health protection as the produce safety regulation, nor did you provide data or information to allow the FDA to conduct such an evaluation.

For more information on consideration of whether processes and procedures used in lieu of an FDA food safety regulation provide the same level of public health protection, see FDA’s Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507, which you may find at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-considerations-determining-whether-measure-provides-same-level-public-health

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.

In addition, we offer the following comments:

  • The foreign supplier 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, as defined in 21 CFR 1.500. For your Pitahaya (Dragonfruit), Pasilla Chili Peppers (Poblano), Jalapeno Peppers, and other fresh produce that you import, the foreign supplier is the grower. During our inspection, you provided the following documentation related to the packinghouse, however you did not provide records or explain how these records relate to the grower nor did you explain how these records establish the packinghouse as a foreign supplier:
  • Appendix E PACKINGHOUSE: (b)(4)
  • Certificate of microbiological analysis of packinghouse hand hygiene water
  • Certificate of microbiological analysis of packinghouse conveyor belt #1
  • (b)(4) audit for (b)(4) (packinghouse)

• During the inspection our investigator discussed the modified requirements of a very small farm and how your supplier could qualify as a very small farm. If you are importing food from a small foreign supplier as specified in 21 CFR 1.512(a)(2) and you choose to comply with the regulation’s requirements, you must obtain written assurance that your foreign supplier meets the criteria in 21 CFR 1.512(a)(2) before first approving the supplier for an applicable calendar year and thereafter on an annual basis by December 31 of each calendar year, per 21 CFR 1.512(b)(1)(ii). If your foreign supplier is a farm that grows produce and is not a covered farm under 21 CFR part 112 in accordance with § 112.4(a), or in accordance with §§ 112.4(b) and 112.5, and you choose to comply with the requirements in 21 CFR 1.512(a)(2), you must obtain written assurance, before importing the produce and at least every 2 years thereafter, that the farm acknowledges that its food is subject to section 402 of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that its food is subject to relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States), in accordance with 21 CFR 1.512(b)(3)(iii).

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. Please provide an English translation of any records that you provide in a language other than English in order to facilitate our review. If you believe that your products 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: Jeff Gard, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Jeff Gard via email at jeff.gard@fda.hhs.gov. Please reference CMS # 670016 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/

Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

 
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