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CLOSEOUT LETTER

Cepheid Ab 12/06/2017

Cepheid Ab - Close Out Letter 6/12/17


Cepheid Ab

 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

JUN 12, 2017

Ms. Anita E. Herrstom Sjoberg
Vice-President and Managing Director
Cepheid Ab
Roentgenvaegen 5
Solna, Sweden

Dear Ms. Herrstrom Sjoberg:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS #470862 issued on July 23, 2015. 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 wi ll not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/

Alberto Gutierrez
Director
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health