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  5. Myllan-ORA ehf - 637443 - 02/09/2023
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Myllan-ORA ehf MARCS-CMS 637443 —

Food & Beverages

Recipient Name
Mr. Hermann Stefansson
Recipient Title
Myllan-ORA ehf

Vesturvor 12
200 Kopavogur

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.

Nick Long
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

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