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  5. Earthborn Products, Inc. - 367441 - 05/06/2019
  1. Warning Letters


Earthborn Products, Inc. MARCS-CMS 367441 —

Delivery Method:
United States Postal Service
Food & Beverages

Recipient Name
Sheri L. Braemer
Recipient Title
Earthborn Products, Inc.

3603 1st Ave.
Ste. 403
San Diego, CA 92103
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

19701 Fairchild
Irvine, CA 92612
United States

Dear Ms. Braemer:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated May 2, 2013. Based on our evaluation, it appears 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.

Robert B. Mcnab
Acting Director Compliance Branch
Food and Drug Administration
HAF Division West 5

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