WARNING LETTER
Dry Produce Division USA LLC
MARCS-CMS 614834 —
June 30, 2021
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Julio A. Salcedo
Recipient Title
Manager
Dry Produce Division USA LLC
5800 S. 42nd St, Ste G
McAllen
,
TX
78503
United States
Issuing Office:
Division of Southwest Imports
United States
WARNING LETTER
June 30, 2021
Re: CMS 614834
Dear Mr. Julio Salcedo:
From March 24 through 26, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Dry Produce Division USA LLC, located at 5800 S. 42nd St, Suite G, McAllen, TX, 78503. We also conducted an inspection on July 24, 2018. 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 our most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for food products that you import including dried Guajillo chili peppers and pumpkin seeds (roasted and salted) imported from foreign supplier Distribuidora de Productos Deshidratados, located in Zacatecas, Mexico and dried chickpea beans imported from Distribuidora de Productos Deshidratados, located in Nuevo Leon, Mexico. You did not have FSVPs for these products or any of the foods that you import. Because of these significant violations, you are not in compliance with Section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on July 24, 2018 and the follow-up inspection ending on March 26, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. As of the date of this letter, we have not received your response to either Form FDA 483a.
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, maintain, and follow an FSVP for any of the foods you import including each of the following food products:
• Dried Guajillo chili peppers imported from Distribuidora de Productos Deshidratados located in Zacatecas, Mexico.
• Pumpkin seeds (roasted and salted) imported from Distribuidora de Productos Deshidratados located in Zacatecas, Mexico.
• Dried Chickpea Beans from Distribuidora de Productos Deshidratados located in Nuevo Leon, Mexico.
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.
(b)(3)(A)
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
(b)(3)(A)
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in 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. We may place the foods you import 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 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 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: Attention: Alina A. Schmidt, Compliance Officer, 2320 Paseo de las Americas, Suite 200, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Alina A. Schmidt via email at alina.schmidt@fda.hhs.gov. Please reference CMS # 614834 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/
Todd Cato
Program Division Director
Division of Southwest Imports
Content current as of:
07/20/2021
Regulated Product(s)
Food & Beverages