https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dulces-la-mejor-llc-615986-09152021
WARNING LETTER
Dulces La Mejor, LLC
MARCS-CMS 615986 — SEPTEMBER 15, 2021
September 15, 2021
Re: CMS # 615986
Dear Mr. Campos:
On June 2 and 16, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Dulces La Mejor, LLC, located at 4330 Tejasco, San Antonio, TX 78218-5240. We also conducted an inspection on July 25, 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 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 initial FSVP inspection on July 25, 2018 and the follow-up inspection on June 16, 2021, our investigator provided you with a Form FDA 483a FSVP Observations.
We acknowledged receipt of your responses dated June 17, 2021 and August 3, 2021, and we address your responses below. Your response on June 17, 2021 stated “I, Maurilio Campos, will be the qualified individual responsible for implementing the FSVP. I’m currently taking the online part 1 and as soon as the part 2 “instructor led class” is available, I will be taking it to get the certificate. After that I will start to develop the FSVP for all my suppliers. I will try to have it ready in about 3 months.” Further, on August 3, 2021, you provided a certificate of training for successfully completing the Food Safety Preventive Controls Alliance course: Foreign Supplier Verification Programs, completed on July 15, 2021. In addition, you stated “I’ve been working on putting FSVP together as much as possible, I have scheduled a couple of visits within the next 3 months to my suppliers (b)(4). I will try to have completed all my suppliers in about 4-6 months.” However, you did not provide evidence of the steps you have taken to develop an FSVP for the food products you import so we are unable to evaluate the adequacy of your response.
Your significant violations of the FSVP regulation are as follows:
You did not develop, maintain, and follow a 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 of the food products you import, including each of the following food products:
Coco Amarillo imported from (b)(4)
Dulce De Calabaza Cristalizado imported from (b)(4)
Papas Caseras a la Diabla imported from (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. 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: 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 # 615986 on any documents or records you provide to us and/ or on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Todd Cato
Director, Southwest Imports
CMS case file #615986
FEI: 3006851223
(b)(5)
4330 Tejasco, San Antonio, TX 78218: 210-787-7953
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