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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Penumbra, Inc. Close out Letter 9/21/10

   

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

Public Health Service
Food and Drug Administration
  San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone: 510/337-5700 

September 21, 2010


Mr. Adam Elsesser
Chief Executive Officer
Penumbra, Inc.
1351 Harbor Bay Parkway
Alameda, CA 94502


Dear Mr. Elsesser:


The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated December 31, 2009. 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/
Barbara J. Cassens
District Director
San Francisco District Office