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  5. Bella Mia Foods, Inc. - 653886 - 07/06/2023
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WARNING LETTER

Bella Mia Foods, Inc. MARCS-CMS 653886 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Leonard Pesce & Mr. Nicholas Pesce
Recipient Title
President/CEO & Manager
Bella Mia Foods, Inc.

99 Ellis Street
Staten Island, NY 10307
United States

Issuing Office:
Division of Northeast Imports

United States


WARNING LETTER

July 6, 2023

Re: CMS # 653886

Dear Mr. Leonard Pesce & Mr. Nicholas Pesce:

On February 1, 2023 through February 9, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Bella Mia Foods, Inc. located at 99 Ellis Street, Staten Island, NY 10307. We also conducted FSVP inspections on August 3, 2017; March 4, 2020; and February 14, 2022 through April 5, 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: 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 current inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We acknowledge receipt of your response dated February 9, 2023, in which you included a document you identified as a “template” that did not describe procedures or include information about any specific food or foreign supplier. You also responded on February 16, 2023, (b)(3)(A) We are unable to evaluate the adequacy of your response because you did not provide any supporting documentation demonstrating your planned corrective actions or steps you will take to comply with the FSVP regulation.

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

  • Chili powder pepper, imported from (b)(4);
  • Cheese, imported from (b)(4); &
  • Pastries, imported from (b)(4).

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 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 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 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 # 653886 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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