- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameFederico Vega Davila
- FVD Produce, LLC
9901 S Jackson Rd
Pharr, TX 78577-6924
- Issuing Office:
- Division of Southwest Imports
August 15, 2023
Re: CMS # 656431
Dear Mr. Davila:
On February 8 through and March 9, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of FVD Produce, LLC, 9901 S Jackson Rd, Pharr, TX 78577-6924. We also conducted an inspection on May 20, 2021. 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-foreignsupplier-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 March 9, 2023.
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 foods that you import, including the following foods:
- Fresh tomatoes, husk tomatoes, carrots and various onions from (b)(4), located in (b)(4)
- Carrots from (b)(4) located in (b)(4)
During our inspection, you provided (b)(4) certificates for (b)(4) and (b)(4). However, the documents that are relevant to an FSVP were incomplete, and you did not provide a record of your review of the relevant documents or explain how they would apply to your FSVP program. Additionally, you no longer import food from these foreign suppliers. Other than the certificates from foreign suppliers from which you no longer import, you did not provide any other documents. Thus, the documents you provided do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).
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 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: Lisa Puttonen, Compliance Officer, Division of Southwest Imports, One Main Place, 1201 Main St, Suite 7200, Dallas, Texas 75202. If you have any questions regarding this letter, you may contact Lisa Puttonen via email at email@example.com. Please reference CMS # 656431 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Southwest Imports Program Director
1201 Main Street
Dallas, TX 75202