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WARNING LETTER

Guillermo Osuna MARCS-CMS 614265 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Guillermo Antonio Osuna
Recipient Title
President
Guillermo Osuna

4843 Faintail Place
San Diego, CA 92154-8906
United States

Issuing Office:
Division of Southwest Imports

United States

WARNING LETTER

June 25, 2021

Re: CMS #614265

Dear Mr. Osuna:

On February 23, 2021, through March 1, 2021, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of your firm Guillermo Osuna located at 4843 Faintail Place, San Diego, CA 92154-8906. We also conducted an onsite inspection on February 13, 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 your cucumber-lemon bottled water, hibiscus-jamaica bottled water, and lychee bottled water, all imported from your foreign supplier Envasadora La Suprema SA de CV. You did not have FSVPs for these products or for any other foods you import. Because of this significant violation, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of both the initial FSVP inspection on February 13, 2019 and the most recent inspection ending on March 1, 2021, our investigator provided you with Form FDA 483a, FSVP Observations. We have not received your response to either Form FDA 483a.

Your significant violation of the FSVP regulation is 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, your firm did not develop an FSVP for each of the following foods:

a. Cucumber-lemon bottled water imported from Envasadora La Suprema SA de CV located in Mexico
b. Hibiscus-Jamaica bottled water imported from Envasadora La Suprema SA de CV located in Mexico
c. Lychee bottled water imported from Envasadora La Suprema SA de CV located in Mexico

The above violation is 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 food products you import for which you appear to be in violation of section 805. 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: Rosa Linda Santos, Compliance Officer, US FDA, 7201 Main St., Suite 7200, Dallas, TX 75202. If you have any questions regarding this letter, you may contact CO Santos via email at rosa.santos@fda.hhs.gov. Please reference CMS #614265 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
District Director
Division of Southwest Imports

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