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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Acclarent, Inc. - Close Out Letter 1/22/14

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700

 

January 22, 2014


Bridget A. Ross
President
Acclarent, Inc.
1525-B O'Brien Dr.
Menlo Park, CA 94025-1463


Dear Ms. Ross:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 394263 dated March 20, 2013, and Warning Letter 296018 dated June 14, 2012. Based on our evaluation, it appears that you have addressed the violations contained in these Warning Letters. 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/

Kathleen M. Lewis, J.D.
District Director
San Francisco District