FDA warns produce importer about violations of Foreign Supplier Verification Program
As part of its application activities, the Food and Drug Administration sends warning letters to the entities under its jurisdiction. Some letters are only displayed for the public before weeks or months after sending. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued as long as a company has had no months to correct the problems. The FDA frequently operates parts of warning letters to protect companies.
Ad Berres @ more llc
McAllen, tx
In a warning letter sent to the owner of the company Arturo J. Garcia, the FDA described an inspection from May 22 to May 28, 2025 when it found serious problems with the verification program for foreign suppliers of the company (FSVP) in Ad Berries @ More LLC located at 1300 N. 10th St. Ste 330a, McAllen, TX. The agency also carried out an inspection from November 28 to November 30, 2022. These inspections were carried out to determine compliance with the requirements of article 805 of the federal law on food, drugs and cosmetics (FD & C ACT) (21 USC 384A) and the FSVP implementation regulations in 21 CFR, L. sub-part.
The FSVP regulations require importers to carry out certain risk-based activities to verify that human and / or animal food that they import to the United States have been produced in a manner that meets applicable American food safety standards.
During the most recent inspection, we have found that you are not in accordance with the requirements of 21 CFR Part 1, sub-part of the food you import. Due to these important violations, you are not in accordance with article 805 of the FD & C law.
At the end of the inspection, our investigator provided you with FDA 483A FSVP observations.
We recognize the reception of your response, dated 4/4/2025 in which you have declared that your business regrets not having been ready with all the documents requested and would take the necessary measures to prepare your files for the next inspection. We are unable to assess the adequacy of your response because you have not provided any support documentation demonstrating your corrective actions. To date, no additional FSVP document has been received by the FDA.
Your important violations of the FSVP regulations are as follows:
You have not developed, maintained and followed up an FSVP. More specifically, you have not developed FSVP for any of the foods you import to the foreign suppliers indicated in the attached list, including each of the following foods:
- Avocados Hass fresh, imported from (Raised)located in (Raised)
- Fresh celery, imported from (Raised)located in (Raised)
- Avocados Hass fresh, imported from (Raised)located in (Raised)
You import fresh products which can be considered as “covered products” as defined in 21 CFR 112.3. If after examining the fresh products that you import, you determine that you are an importer of covered products, you must have an FSVP which demonstrates that your supplier produces food in accordance with the processes and procedures which provide at least the same level of public protection as those required under American law.
The above violations are not intended to be a global list of violations of the FSVP requirements.
This letter informs you of our concerns and offers you the possibility of resolving them. If you do not adequately deal with this question, we can take new measures. For example, we can take measures under article 801 (a) (3) of the FD & C law (21 USC 381 (a) (3)) to refuse the admission of the food you import for which you seem to be in violation of article 805. We can place food[s] of the identified foreign supplier[s] In detention without physical examination (DWPE) when you import food.
The complete warning letter can be found here.
(Please print this email if necessary. THANKS!))
