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  5. Desserts by Helen, Inc. - 659181 - 03/15/2024
  1. Warning Letters

CLOSEOUT LETTER

Desserts by Helen, Inc. MARCS-CMS 659181 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Craig A. Friedman
Recipient Title
Vice President
Desserts by Helen, Inc.

283 Thompson Avenue
Louisville, KY 40206-1071
United States

craig@dessertsbyhelen.com
Issuing Office:
Division of Human and Animal Food Operations East V

United States

Secondary Issuing Offices

United States

Dear Mr. Friedman:

The Food and Drug Administration has completed evaluation of Dessert by Helen Inc. corrective actions in response to our Warning Letter 659181, dated September 11, 2023. Based on our evaluation, it appeared that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
Allison C. Hunter
Compliance Officer
Office of Human & Animal Foods Operations
East 5 Division

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