BrainAlert, LLC

CLOSEOUT LETTER BrainAlert, LLC April 27, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: BrainAlert, LLC United States Issuing Office: United States 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 Content current as of: 05/08/2018