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CLOSEOUT LETTER

Seedling Enterprise, LLC MARCS-CMS 484628 — Feb 14, 2019

Seedling Enterprise, LLC - 484628 - 02/14/2019


Recipient:
Recipient Name
Peter Klein
Recipient Title
Owner
Seedling Enterprise, LLC

6717 111th Ave
South Haven, MI 49090
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

550 W. Jackson Blvd.
Suite 1500
Chicago, IL 60661
United States


Dear Mr. Klein,

The Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter, 2016-DET-11, dated May 19, 2016. 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.

Sincerely,
/S/
Byron J. Ho, DVM
Compliance Officer
Human and Animal Food Division East 6