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WARNING LETTER

Mr Lukas LLC MARCS-CMS 613441 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Luis Barrera
Recipient Title
Owner
Mr Lukas LLC

1122 Pecan Blvd.
McAllen, TX 78501
United States

Issuing Office:
Division of Southwest Imports

United States


WARNING LETTER

April 9, 2021

Re: CMS #613441

Dear Mr. Barrera,

On January 25-28, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of records that your firm was asked to submit to FDA. We also conducted an inspection on August 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 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 inspection, we found that you are not in compliance with the requirements of 21 CFR Part 1 subpart L for the foods you import including, but not limited to: canned nacho sliced jalapenos, Mexican style hominy and tomato tomatillo imported from (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 most recent inspection on January 28, 2021, and the initial FSVP inspection on August 29, 2018, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We have not received your response to either of the Form FDA 483a.

Your significant violation is described below:

You did not develop FSVPs as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, your firm did not develop FSVPs for the foods you import from (b)(4), including but not limited to canned nacho sliced jalapenos, Mexican style hominy, and tomato tomatillo.

We acknowledge you informed our investigator during the inspection that you (b)(4). You also stated you would notify your foreign supplier and your U.S. Customs Broker to (b)(4). To date, we have not received a written commitment from you that (b)(4), our records show you continue to import foods. Please note, as long as you continue to import covered foods into the United States and you meet the definition of an importer as defined in section 805(a)(2) of the FD&C Act and 21 CFR 1.500, you are the FSVP importer and you are required to comply with FSVP requirements.

During our most recent inspection we acknowledge you provided information to demonstrate you may (b)(4), and may choose to (b)(4). However, you have not (b)(4). Regardless of (b)(4), you are still required to follow FSVP requirements. If you choose to (b)(4), you must document that you (b)(4), (b)(3)(A)

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 food products you import that appear to be in violation of section 805. We may place the foods 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.

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 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: Barbara Rincon, Compliance Officer, Division of Southwest Imports. If you have any questions regarding this letter prior to your written response, you may contact Barbara Rincon, at telephone number (619) 941-3691 or via email at Barbara.Rincon@fda.hhs.gov. Please reference CMS #613441 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 Program Division Director

 
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