- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Mario Hidalgo
- Mario Hidalgo DBA Distribuidora de Productos Alimenticios El Paisita
7404 N. 34th St.
McAllen, TX 78504
- Issuing Office:
- Division of Southwest Imports
July 12, 2021
Re: CMS # 614478
Dear Mr. Mario Hidalgo,
On March 9-10, 2021, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of your firm Mario Hidalgo DBA Distribuidora de Productos Alimenticios El Paisita, located at 4712 N. 12th St., Apt. 47 McAllen, TX 78504-3604. We also conducted an inspection on November 29, 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 Foreign Supplier Verification Program (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/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During our inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import, including Glorias w/Pecan Milk Candy and White Coconut Candy, both from Distribuidora De Productos Alimenticios El Paisita, Emiliano Carranza, located in Mexico and Tejocote (b)(4) from (b)(4), located in (b)(4). You did not have FSVPs for these food products or for any products you import. Because of this significant violation, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the initial FSVP inspection on November 29, 2018 and the current inspection on March 9-10, 2021, our investigator provided you with Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated March 23, 2021 in which you stated that you planned to attend a Qualified Individual FSVP Training on March 29-30, 2021 and that you identify your firm as a very small importer based on a sales volume of less than 1 million dollars in the last three years. You also stated that you were requesting letters from your small foreign suppliers asking them “to explain what they do to ensure that the products they manufacture are safe for health or equivalent to US standards and will have them ready in my import records.” We contacted you on April 23, 2021 to follow up regarding whether you had attended the planned FSVP training on March 29-30 or had taken other steps to develop your FSVP, but we have not received a response to that communication. The FSVP implementation information you have provided thus far is not sufficient or specific enough to evaluate its adequacy at this time.
Your significant violation 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 part 1.502(a). Specifically, your firm did not develop an FSVP for any of the foods you import, including each of the following:
a. Glorias W/Pecan Milk Candy imported from Distribuidora De Productos Alimenticios El Paisita, located in Mexico.
b. White Coconut Candy imported from Distribuidora De Productos Alimenticios El Paisita, located in Mexico.
c. Tejocote (b)(4) imported from (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.
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 foods you import, including Glorias W/Pecan Milk Candy and White Coconut Candy manufactured by Distribuidora De Productos Alimenticios El Paisita and Tejocote (b)(4) manufactured by (b)(4) that appear to be in violation of section 805. We may place these foods you import from the identified foreign supplier 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 (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 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 the Food and Drug Administration, Attention: CDR Toby H. Hill, Compliance Officer, Division of Southwest Imports, One Main Place, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have any questions regarding this letter, you may contact Compliance Officer CDR Toby H. Hill via email at firstname.lastname@example.org. Please reference CMS # 614478 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Division of Southwest Imports Director
One Main Place
1201 Main Street, Suite 7200
Dallas, TX 75202