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  5. Ikal LLC - 660717 - 08/07/2023
  1. Warning Letters

WARNING LETTER

Ikal LLC MARCS-CMS 660717 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Adriana Valadez Ricalde
Recipient Title
President
Ikal LLC

8766 Sherwood Terrace
San Diego, CA 92154
United States

Issuing Office:
Division of Southwest Imports

United States

August 7, 2023

WARNING LETTER

Re: CMS # 660717

Dear Ms. Valadez Ricalde,

On April 26 through May 1, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Ikal, Llc., located at 8766 Sherwood Terrace, San Diego, CA 92154. We also conducted an inspection on May 14 through May 20, 2021. 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-foreignsupplier-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 Form FDA 483a, FSVP Observations. We acknowledge receipt of your written response, dated May 2, 2023. In your response you stated that, prior to the most recent inspection, you had hired a consultant and thought you already had an FVSP for your avocados, but you found it was not complete; you attached invoices from the consultant you hired to help with your FSVP. You then said you would take an FSVP course in June, contact the consultant you already hired, and determine if you needed to hire someone to be your FSVP agent. You requested six months to complete your FSVP. On May 11, 2023, we received your response with an invoice for an FSVP course, followed by your email on July 3, 2023, with a copy of your Certificate of Training for FSVP, dated June 16, 2023, from the Food Safety Preventive Controls Alliance (FSPCA). We are unable to evaluate the adequacy of your responses because, other than your Certificate of Training for FSVP, you have not provided any supporting documentation demonstrating your planned or completed corrective actions. To date, no additional FSVP documents have been received by FDA.

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 part 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following:

• Fresh avocados imported from (b)(4)
• Fresh avocados imported from (b)(4)
• Fresh avocados imported from (b)(4)

You import fresh produce, that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. § 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).

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. 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 which appear to be in violation of section 805. We may place these foods you import into the United States 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 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 the Food and Drug Administration, Attention: Ernesto Barba, Compliance Officer, Division of Southwest Imports, 9725 Via de la Amistad, Ste 200, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Compliance Officer Ernesto Barba via email at Ernesto.Barba@fda.hhs.gov. Please reference CMS # 660717 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/

Alexander Lopez
Acting Director
Division of Southwest Imports
One Main Place
1201 Main Street, Suite 7200
Dallas, TX 75202

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