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  5. BrainAlert, LLC - Close Out Letter 4/27/18
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CLOSEOUT LETTER

BrainAlert, LLC


Recipient:
BrainAlert, LLC


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Seattle District Office
22215 261h Avenue SE, Suite 210
Bothell, Washington 98021 

April 27, 2018
 

OVERNIGHT DELIVERY
SIGNATURE REQUIRED

Jared K. Lykken, Distributing Agent
BrainAlert, LLC
3116 1641h Street SW, Unit #1106
Lynnwood, Washington 98087

Dear Mr. Lykken:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 535653, dated December 14, 2017. 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
Program Division Director