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WARNING LETTER

World Candy Store LLC MARCS-CMS 611073 —

Product:
Food & Beverages
Recipient:
World Candy Store LLC

United States

Issuing Office:
Division of Southwest Imports

United States

November 3, 2020

WARNING LETTER


Re: CMS # 611073

Dear Mr. Ramirez,

From September 3 to 11, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of World Candy Store LLC, located at 1921 Anei Circle, Brownsville, Texas 78521. We also conducted an inspection on August 17, 2017. 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 food products you import including, but not limited to, Ricolino Huevito Pinto imported from foreign supplier (b)(4), and Ricolino Huevito imported from foreign supplier (b)(4). You did not have FSVPs for these products. 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 in August 2017 and the follow-up inspection in September 2020, our investigator provided you with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response via email dated October 2, 2020, in which you provided a document titled, “FSVP Implementation Plan.” This document stated you have hired a qualified individual, Mr. (b)(6), (b)(4), to “create and develop the new FSVP” for you. This document also provides target dates for additional actions, including to “[c]reate new procedures to integrate all the aspects of the FSVP.” We are unable to evaluate the adequacy of this response because you did not provide any documents or records related to your FSVP program. Additionally, we note that at the conclusion of the initial FSVP inspection in August 2017, our investigator provided you with a Form FDA 483a, to which you responded that you “had hired a professional advisor (Mr. (b)(6), (b)(4)) to work full time in our company commencing last Monday August 28, 2017 and its only task will be the implementation of FSVP inside our company.” However, to date, you still have not provided FSVPs for any of the food products you import.

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 of the food products you import, including:

• Ricolino Huevito Pinto imported from (b)(4)
• Ricolino Huevito 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.

You should take prompt action to correct the above violations. If you do not promptly correct them, 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. We may place the food products 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 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: Attention: Kendra J. Vieira, Compliance Officer, 2320 Paseo de las Americas, Suite 208, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Kendra J Vieira via email at Kendra.Vieira@fda.hhs.gov.

Please reference CMS # 611073 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

 
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