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CLOSEOUT LETTER

Vi-Jon, LLC MARCS-CMS 622087 —

Delivery Method:
UPS Next Day
Product:
Drugs

Recipient:
Recipient Name
Mr. Richard Koulouris
Recipient Title
Chairman and CEO
Vi-Jon, LLC
Consumer Product Partners, LLC

8800 Page Avenue
St. Louis, MO 63114
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

United States

Secondary Issuing Offices

United States


Dear Mr. Koulouris:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS # 622087], dated March 31, 2022. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter.

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

 
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