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  5. Facema, LLC. - 640528 - 10/18/2022
  1. Warning Letters

WARNING LETTER

Facema, LLC. MARCS-CMS 640528 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Fernando Gallardo and Mr. Mario Gallardo
Recipient Title
Owner & General Manager
Facema, LLC.

9385 Washington Blvd N., Suite H
Laurel, MD 20723
United States

Issuing Office:
Division of Northeast Imports

United States

WARNING LETTER

Re: CMS 640528

Dear Mr. Fernando Gallardo & Mr. Mario Gallardo:

On May 20, 2022 through August 3, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Facema, LLC. located at 9385 Washington Blvd N., Suite H, Laurel, MD 20723. We also conducted FSVP inspections on September 25 - 26, 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 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 August 3, 2022.

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 foods that you import, including the following food:

  • Tomato sauce (with other ingredients) imported from (b)(4), located in (b)(4);
  • Toffee candy imported from Facema S.A. de C.V. located in Nicaragua; and
  • Peanuts imported from (b)(4) located in (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.

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 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 FSVPs, records to demonstrate implementation of your FSVPs), 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 Food and Drug Administration, Attention: David Trent-Carlson, Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLRESPONSES@fda.hhs.gov. Please also cc (carbon copy) David.Trent-Carlson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at David.Trent-Carlson@fda.hhs.gov. Please reference CMS # 640528 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Theresa Smedley
Acting Program Division Director
Division of Northeast Imports

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