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  5. Brad D. Smith - 596961 - 07/22/2020
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Brad D. Smith MARCS-CMS 596961 —

Delivery Method:

Recipient Name
Brad D. Smith
Brad D. Smith

3741 220th St
Estherville, IA 51334-7621
United States

Issuing Office:
Office of Human and Animal Food –

United States


Dear Mr. Brad D. Smith:

The Food and Drug Administration has completed an evaluation of Brad D. Smith corrective actions in response to our Warning Letter (CMS case #: 596961) on September 23, 2019. Based on our evaluation, it appears that you have addressed the violation(s) 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.

Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West

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