WARNING LETTER
Del Valle Import & Export 3, Inc. DBA El Progreso Imports
MARCS-CMS 657322 —
July 18, 2023
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Nely Olivera Garcia
Recipient Title
President/Chief Executive Officer
Del Valle Import & Export 3, Inc. DBA El Progreso Imports
2824 E 54th St
Vernon
,
CA
90058-3632
United States
Issuing Office:
Division of West Coast Imports
United States
July 18, 2023
WARNING LETTER
Re: CMS #657322
Dear Ms. Nely Olivera Garcia:
From February 22, 2023 through February 28, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at Del Valle Import & Export 3, Inc. dba El Progreso Imports located at 2824 E 54th St, Vernon, CA 90058-3632. We also conducted inspections from September 7 through September 13, 2022; February 4 through March 5, 2021; and February 6 through February 12, 2019. 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 FSVP implementing 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/GuidanceRegulation/FSMA/ucm361902.htm
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 from the foreign suppliers indicated in the list provided during the inspection. 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.
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 the foods from the foreign suppliers indicated in the list provided during the inspection.
Your written response dated March 20, 2023, provided FSVP records from your current consultant for your Corn Chip Snacks, imported from
(b)(4)
. You also provided FSVP records from 2020 and 2021 from your previous consultant for your Plantain Chips imported from
(b)(4)
and Banana Soft Drink imported from
(b)(4)
. However, your written response did not provide records for any other products you import. Your written response also stated that you were taking a number of actions to show that you are in the process of
(b)(4)
. However, we cannot evaluate the adequacy of these corrective actions because your written response does not indicate that you have completed any of these actions or provided a timeframe for doing so. We will evaluate the adequacy of any corrective actions at the next FSVP inspection.
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 products you import for which you appear to be in violation of section 805. We may place the foods you import 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 these 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 revised 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 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: Dennis N. Hoang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831, with a copy via electronic mail to WCID@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Hoang via email at dennis.hoang@fda.hhs.gov. Please reference CMS #657322 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/
Kathleen Turner, DVM
Program Division Director
Division of West Coast Imports
Content current as of:
09/12/2023
Regulated Product(s)
Food & Beverages