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WARNING LETTER

Espifresh Inc. MARCS-CMS 724452 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Oscar Espinoza Farias
Recipient Title
CEO
Espifresh Inc.

3516 E. Olympic Blvd
Los Angeles, CA 90023-3924
United States

espifresh@yahoo.com
Issuing Office:
Office of Inspections and Investigations

United States

March 6, 2026

WARNING LETTER

Re: CMS # 724452

Dear Mr. Espinoza Farias:

From January 21, 2026, through January 28, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Espifresh Inc, located at 3516 E. Olympic Blvd, Los Angeles, CA 90023-3924. We also conducted an inspection from July 17, 2025, through July 30, 2025. 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 United States 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 February 18, 2026, in which you acknowledged that you do not have an FSVP in place for all of your suppliers as required by 21 CFR 1.502. You indicated that you have designated a qualified individual for FSVP development and compliance, updated your FSVP procedure, and committed to documenting the evaluations for each foreign supplier (b)(4), and establishing verification activities (b)(4). You also provided the following documents: Espifresh Inc FSVP SOP, FSPCA Training Certificate for (b)(6), (b)(7)(C) and Authorization Letter authorizing third-party consultant, (b)(4), to represent your firm in FSVP inspection matters. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions. To date, no additional FSVP documents have been received by FDA.

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 you import, including each of the following foods:

  • Fresh Chayote, imported from (b)(4), located in (b)(4).
  • Fresh Pacaya, imported from (b)(4), located in (b)(4).
  • Fresh Flower (b)(4), imported from (b)(4), located in (b)(4).
  • Fresh Mango, imported from (b)(4), located in (b)(4).

During our inspection you provided the investigator documents for Nanches in (b)(4) from (b)(4), located in (b)(4). However, you could not explain how these documents would apply to your FSVP program.

You import fresh produce that may be considered “covered produce” as defined in 21 CFR 112.3. If after review of the fresh produce that you import you determine that you are 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.

In addition, FDA has determined that your facility located at 3516 E. Olympic Blvd, Los Angeles, CA 90023-3924 (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. 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: Celena Ngo, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Celena Ngo via email at celena.ngo@fda.hhs.gov.

Please reference CMS # 724452 on any documents or records you provide to us and on 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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