FDA warns produce importer about violations of Foreign Supplier Verification Program

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts portions of warning letters to protect companies.

A.D. Berries @ More LLC
McAllen, TX

In a warning letter sent to company owner Arturo J. Garcia, the FDA described an inspection from May 22 through May 28, 2025 when it found serious problems with the firm’s Foreign Supplier Verification Program (FSVP) at A.D. BERRIES @ MORE LLC located at 1300 N. 10th St. Ste 330a, McAllen, TX. The agency also conducted an inspection on Nov. 28 through Nov. 30, 2022. 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. 

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 6/4/2025 in which you stated that your firm regrets not having been ready with all the documents requested and will be taking the necessary measures to get your files ready for the next inspection. 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. Specifically, you did not develop an FSVP for any of the foods you import from the foreign suppliers indicated in the attached list, including each of the following foods:

• Fresh Hass Avocados, imported from (redacted), located in (redacted)
• Fresh Celery, imported from (redacted), located in (redacted)
• Fresh Hass Avocados, imported from (redacted), located in (redacted)

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 U.S. law.

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. 

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 food[s] from the identified foreign supplier[s] on detention without physical examination (DWPE) when you import the foods.

The full warning letter can be found here.

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Source: https://www.foodsafetynews.com/2025/08/fda-warns-produce-importer-about-violations-of-foreign-supplier-verification-program/