U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Wellmill LLC dba Vitamix - Close Out Letter 1/9/17
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Wellmill LLC dba Vitamix Jan 09, 2017

Wellmill LLC dba Vitamix - Close Out Letter 1/9/17


Wellmill LLC dba Vitamix

 

  

Black HHS-Blue FDA Logo

 

 

 
New York District
158-15 Liberty Ave
Jamaica, NY 11433
 

1/9/2017

Mr. Michael Koschitz, President
Wellmill LLC dba Vitamix
69 Mall Drive
Commack, NY 11725

Dear Mr. Koschitz:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, NYK-2015 issued on December 18, 2014. 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.

If you have questions regarding this letter, please contact CDR Frank Vemi, Compliance Officer at 718-662-5702.
 

Sincerely,
/S/

Ronald M. Pace
District Director
New York District