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  5. The Elderberry Company - 608837 - 01/26/2022
  1. Warning Letters

CLOSEOUT LETTER

The Elderberry Company MARCS-CMS 608837 —

Delivery Method:
VIA Electronic Mail
Product:
Dietary Supplements
Recipient:
Recipient Name
Jennifer C. Watson
Recipient Title
Owner
The Elderberry Company

302 Pearl Street Suite B
New Albany, IN 47150
United States

Issuing Office:
Office of Human and Animal Food Operations East-VI

United States

Dear Ms. Watson:

The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY20-HAFE6-WL-05, issued on 09/08/2020. Based on our evaluation, it appears the 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/
Kelli Wilkinson LCDR
Director of Compliance
Office of Human and Food Operations
Division East 6

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