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  5. Lacteos Mi Chalatenango, Inc. - 655717 - 06/12/2023
  1. Warning Letters

WARNING LETTER

Lacteos Mi Chalatenango, Inc. MARCS-CMS 655717 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Maria Maribel Flores
Lacteos Mi Chalatenango, Inc.

825 Geranium Ave E
Saint Paul, MN 55106
United States

Issuing Office:
Division of Northern Border Imports

United States

Secondary Issuing Offices

United States

June 12, 2023

WARNING LETTER

Re: CMS # 655717

Dear Ms. Maria Maribel Flores:

From February 09, 2023 through March 22, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Lacteos Mi Chalatenango, located at 841 7th Street E, Suite A, Saint Paul, MN 55106. We also conducted an inspection from August 22, 2022 through August 25, 2022. 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 FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals | FDA

During the 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 a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a issued on March 22, 2023.

Your significant violations of the FSVP regulation are as follows:

1. As a very small importer, for each food you import, you must obtain written assurance, in accordance with 21 CFR 1.512(b)(3), before importing the food and at least every two years thereafter, that your foreign 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 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act. During our inspection, you stated that you were a very small importer and provided an income and expenses statement for 2021 and 2022 to support this statement. You told the investigator that you were working on getting written assurances from your suppliers, but you did not have written assurances, as required by 21 CFR 1.512(b)(3), for any of the products you import, specifically:

  • Various candies, imported from (b)(4)
  • Black Sauce, imported from (b)(4)
  • Cheese , imported from (b)(4)
  • Cheese, imported from (b)(4)
  • Hard Candy, imported from (b)(4)

This is a repeat observation from the previous August 2022 inspection.

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 State of an article of food without the importer having 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)).

We also offer the following comment:

At the conclusion of our previous inspection of your firm in August 2022, our investigator provided you with a Form FDA 483a FSVP Observations. We did not receive a response to this Form FDA 483a issued on August 25, 2022. Further, after the inspection was closed, we found that some of your imported products received a positive test analysis for presence of Staphylococcus Aureus. We notified you of this finding and that we determined your food was adulterated under section 402 of the FD&C Act. On October 28, 2022, we placed your product (b)(4) from your supplier (b)(4) and your product (b)(4) from your supplier (b)(4) on Import Alert #12-10 "Detention Without Physical Examination of Cheese Due to Microbiological Contamination", and on January 30, 2023, we placed your product (b)(4) from your supplier (b)(4) on Import Alert #12-10 “Detention Without Physical Examination of Cheese Due to Microbiological Contamination." These foreign suppliers remain on Import Alert #12-10.

You must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food consistent with the assurance provided in accordance with 21 CFR 1.512(b)(3)(i) through (iv), as required by 21 CFR 1.512(b)(4). The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of circumstances have been adequately addressed. You must also document any corrective actions you take in accordance 21 CFR 1.512(b)(4).

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 correction (e.g., documents 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 you delay and state when you will correct any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Alyssa L. Wenke, Compliance Officer, Division of Northern Border Imports. If you have any questions regarding this letter, you may contact Compliance Officer Wenke via email at Alyssa.Wenke@fda.hhs.gov. Please reference CMS #655717 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports

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