Myllan-ORA ehf

CLOSEOUT LETTER Myllan-ORA ehf MARCS-CMS 637443 — February 09, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Mr. Hermann Stefansson Recipient Title CEO Myllan-ORA ehf Vesturvor 12 200 Kopavogur Iceland Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States Dear: Mr. Hermann Stefansson: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 637443, issued August 30, 2022. Based on our evaluation, it appears you have addressed the violations contained in the 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/ Nick Long Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 02/22/2023 Regulated Product(s) Food & Beverages