St. Moritz Bakery Inc

CLOSEOUT LETTER St. Moritz Bakery Inc MARCS-CMS 476843 — May 31, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: St. Moritz Bakery Inc United States Issuing Office: United States 1431 Harbor Bay Parkway Alameda, CA 94502-7070 May 31, 2018 Mr. Manfred H. Maehler, CEO St. Moritz Bakery Inc. dba Mahler’s Bakery 1943 Avenida Plaza Real Oceanside, CA 92056 Dear Mr. Manfred H. Maehler: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 476843), dated March 11, 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/ Sergio Chavez Director of Compliance Office Human and Animal Foods Division West 5 Content current as of: 06/08/2018