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CLOSEOUT LETTER

Finally Pure, LLC Jan 17, 2017

Finally Pure, LLC - Close Out Letter 1/17/17


Finally Pure, LLC

 

  

Black HHS-Blue FDA Logo

 

 

 
Seattle District
22215 26th Avenue SE, Suite 210
Bothell, WA 98021 

January 17, 2017

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Melanie Lindell & Nancy Tarr, Owners
Finally Pure, LLC
P.O. Box 876305
Wasilla, Alaska 99687

Dear Ms. Lindell and Ms. Tarr: 

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 16-15, dated July 20, 2016. Based on our evaluation, it appears that you have addressed the violations 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.
 

Sincerely,
/S/
Miriam R. Burbach
District Director