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  5. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 2 - 487023 - 09/11/2019
  1. Warning Letters

CLOSEOUT LETTER

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 2 MARCS-CMS 487023 —

Delivery Method:
UPS Next Day
Signature Required
Reference #:
# CHI-8-16
Product:
Drugs
Recipient:
Recipient Name
William J. Kalman
Recipient Title
President and Co-Owner
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 2

4625 N University Street
Peoria, IL 61614-5828
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III (PHRM3)

300 River Place
Suite 5900
Detroit, MI 48207
United States

(313) 393-8100

Dear Mr. Kalman:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL # CHI-8-16), dated July 22, 2016. We acknowledge that your firm no longer produces sterile drug products. 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 assure 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.

Sincerely,
/S/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III

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