WARNING LETTER
Full Fresh Produce LLC
MARCS-CMS 726913 —
April 10, 2026
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Abel Fiallo
Recipient Title
General Manager
Full Fresh Produce LLC
17651 SW 187th Ave
Miami
,
FL
33187
United States
Issuing Office:
Office of Inspections and Investigations
United States
April 10, 2026
WARNING LETTER
Re: CMS # 726913
Dear Mr. Abel Fiallo:
On March 9, through March 11, 2026, the U.S. Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Full Fresh Produce LLC, locate at 17651 SW 187th Ave. Miami, FL 33187. We also conducted inspections on June 7, 2021; September 21, 2022; and March 11, 2026. 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 food products 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 FSVP inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your response dated March 12, 2026, and we address your response below.
Your response stated that you will be taking the FSVP training course to become a qualified individual to develop and implement the FSVP’s for your imported foods. We are unable to evaluate the adequacy of your response because you did not provide further details or documentation demonstrating your corrective actions for all the imported foods that your firm identified as not having an FSVP in place. To date, no additional FSVP documents nor a timeframe of completion have been received by FDA.
Your significant violations of the FSVP regulation are as follows:
1. 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 foods that you import, including:
Fresh Mangoes, imported from
(b)(4)
, located in
(b)(4)
Fresh Avocados, imported from
(b)(4)
, located in
(b)(4)
Fresh Blueberries, imported from
(b)(4)
, located in
(b)(4)
You import fresh produce that is “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).
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.
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 foods you import for which you appear to be in violation of section 805 of the FD&C Act. We may place the foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. 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.
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 these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., 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 the foods you import 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 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: Coral del Mar Lopez, Compliance Officer, Division of Southeast Imports, 959 Ridgeway Loop Rd. Suite #100, Memphis, TN 38120. If you have any questions regarding this letter, you may contact Officer Lopez via email at coraldelmar.lopez@fda.hhs.gov. Please reference CMS No. 726913 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/
Christopher Boulmay
Acting Program Division Director, Division of Southeast Imports
Office of Inspections and Investigations
U.S. Food and Drug Administration
U.S. Department of Health and Human Services
Content current as of:
07/14/2026
Regulated Product(s)
Food & Beverages