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  5. Uckele Health & Nutrition, Inc. - 540533 - 10/09/2019
  1. Warning Letters

CLOSEOUT LETTER

Uckele Health & Nutrition, Inc. MARCS-CMS 540533 —

Delivery Method:
VIA UPS
Reference #:
FY18-HAFE6-04
Product:
Dietary Supplements
Recipient:
Recipient Name
Michael J. Uckele
Recipient Title
CEO
Uckele Health & Nutrition, Inc.

5600 Silberhorn Highway
Blissfield, MI 49228
United States

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

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

Dear Mr. Uckele:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (FY18-HAFE6-04, dated March 6, 2018). 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 Ho, DVM
Compliance Officer
Office of Human and Animal Food
Division East 6

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