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  5. The Elderberry Fairy & Co., LLC - 622859 - 04/26/2023
  1. Warning Letters

CLOSEOUT LETTER

The Elderberry Fairy & Co., LLC MARCS-CMS 622859 —

Product:
Dietary Supplements
Recipient:
Recipient Name
Catie Fasno
Recipient Title
Owner
The Elderberry Fairy & Co., LLC

3320 Electric Avenue
Lincoln Park, MI 48146
United States

Issuing Office:
Office of Human and Animal Food Operations East Division 6

United States

Dear Ms. Fasno:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY2022-HAFE6-WL-08. Based on our evaluation, it appears that you have addressed the violation(s) contained in the 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/
LCDR Kelli L. Wilkinson
Compliance Branch Director

 
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