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  5. Nutrishare Inc - 543730 - 03/04/2020
  1. Warning Letters


Nutrishare Inc MARCS-CMS 543730 —

Delivery Method:
UPS Next Day

Recipient Name
Rodney J. Okamoto
Recipient Title
Owner and President
Nutrishare Inc

9850 Kent Street
Elk Grove, CA 95624
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

United States

(313) 393-8100

Dear Mr. Okamoto:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [Case #543730, January 16, 2018]. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III

cc: Gregory M. Killmeier
      Operations Manager & Pharmacist in Charge
      Nutrishare Inc.
      11020 Plantside Drive
      Louisville, KY 40299-6105

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