WARNING LETTER
Zacanta LLC
MARCS-CMS 703125 —
March 05, 2025
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jorge Celis
Recipient Title
Owner
Zacanta LLC
10700 S Sugar Rd
Pharr
,
TX
78577-0624
United States
jcelis@zacanta.com
Issuing Office:
Office of Inspections and Investigations
United States
March 5, 2025
WARNING LETTER
Re: CMS # 703125
Dear Mr. Celis:
On 07/14/2023 – 07/18/2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of ZACANTA LLC located at 10700 S Sugar Rd, Pharr, TX 78577-0624. We also conducted an inspection on 01/14/2025 – 01/27/2025. 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 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 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 02/06/2025.
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 green beans, imported from,
(b)(4)
, located in Mexico
Fresh dark green beans, imported from,
(b)(4)
, located in Mexico
Fresh carrots, imported from,
(b)(4)
, located in Mexico
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.
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 suppliers 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: Virginia Ramos, Compliance Officer, Division of Southwest Imports, Laredo Village Plaza, 217 W. Village, Suite 107, Laredo, TX 78041. If you have any questions regarding this letter, or wish to send your response electronically, you may contact Virginia Ramos via email at Virginia.Ramos@fda.hhs.gov. Please reference CMS # 703125 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Todd Cato
Program Division Director
Division of Southwest Imports
1201 Main Street, Suite 7200
Dallas, TX 75202
Content current as of:
03/18/2025
Regulated Product(s)
Food & Beverages