Sachau, Jake

CLOSEOUT LETTER Sachau, Jake MARCS-CMS 489288 — April 26, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Sachau, Jake United States Issuing Office: United States Office of Human and Animal Food – West Division II 8050 Marshall Drive - Suite 205 Lenexa, Kansas 66214-1524 913-495-5100 April 26, 2018 DELIVERY VIA UPS WARNING LETTER CLOSE-OUT LETTER Jakob D. Sachau, Owner Jake Sachau 2441 I Avenue Denison, IA 51442 Dear Mr. Sachau: The Food and Drug Administration has completed an evaluation of Jake Sachau corrective actions in response to our Warning Letter (CMS case #: 489288) on February 28, 2016. 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. Sincerely, /S/ Miguel A. Hernandez Director, Compliance Office of Human and Animal Food – Division II West Content current as of: 05/02/2018