Delivery Method: Via Express Delivery Product: Food & Beverages

Recipient:

Recipient Name

Mr. Santos David Velasquez

El Salvador Products Inc

12130 Dairy Ashford
Sugarland, TX 77478
United States

Issuing Office: Division of Southwest Imports

United States


September 02, 2022

WARNING LETTER

Re: CMS# 640532

Dear Mr. Santos David Velasquez:

On June 3 - 8, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of El Salvador Products Inc. located at 12130 Dairy Ashford Sugarland, TX 77478. We also conducted an inspection on May 21 - 23, 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 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 June 8, 2022.

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:

  • Salsa & Queso Chips and Sweet Bread imported from (b)(4), located in (b)(4)
  • Pineapple Pastry imported from foreign supplier (b)(4), located in (b)(4)

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.

Additionally, we offer the following comment:

FDA has determined that your facility at 12130 Dairy Ashford Sugarland, TX 77478 is subject to the registration requirement in section 415 of the FD&C Act (21 U.S.C. § 350 d) and our implementing regulations at 21 CFR Part 1, Subpart H. Section 415(a)(3) of the FD&C Act requires facilities that are required to register with FDA to renew their registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. During the inspection you were advised of these requirements. Our records indicate that as of the date of this letter, your firm does not have a valid food facility registration. The failure to register a facility as required is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. § 331(dd)).

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. 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 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: Juan Daniel Garza III, Compliance Officer, US FDA, 216 W. Village Blvd., Suite 107, Laredo, TX 78041. If you have any questions regarding this letter, you may contact CO Garza via email at [email protected] Please reference CMS# 640532 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
Division Director
Division of Southwest Imports