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  5. Maximus Niterider International Group, Inc. - Close Out Letter 3/25/14
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CLOSEOUT LETTER

Maximus Niterider International Group, Inc.


Maximus Niterider International Group, Inc.

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506

Telephone: 949-608-2900
FAX: 949-608-4415

 

 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED


March 25, 2014


Mr. Wagdy M. Morcos, President
Maximus Niterider International Group, Inc.
11810 Greenstone Ave
Santa Fe Springs, CA, 90670


Dear Mr. Morcos:

The purpose of this letter is to acknowledge receipt of your letters dated February 28, 2014 and March 12, 2014, which we received on March 13, 2014. Your letters, which responded to the FDA Warning Letter (WL) 14-14, dated February 11, 2014, will be made a permanent part of our files.

In your letters you stated that you have decided to cease the distributing, marketing and sales of Nite Rider dietary supplement (DS) products, which were the subject of the WL you received. Your letters included documents covering the cancellation of your FDA Food Facility Registration and the destruction of printed dietary supplement capsules, packaging, and labeling of your Nite Rider, Nite Tiger, G-Spark and Quick Fix brand DS products. You further affirmed during a phone call with the agency on March, 20, 2014 that you are getting out of the DS business completely and this is not just limited to those specific products. Your decision to cease the distributing, marketing and sales of dietary supplements appears to have addressed the violation(s) contained in the Warning Letter you received.

Should you decide to resume operations in the future, 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. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

If you have questions regarding any Issues in this letter, please contact David Whitman, Compliance Officer at (619)-941-3769.

 

Sincerely,

/S/

Alonza E. Cruse, Director
Los Angeles District