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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Respironics, Inc.- Close Out Letter 4/12/12

  

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

Public Health Service
Food and Drug Administration
 US.Customhouse Room 900
200 Chestnut Street
Philaqelphia PA 19106
 

April 12, 2012
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. D. Brent Shafer
CEO and GM
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668

Dear Mr: Shafer:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 12-PHI-01, issued October 11, 2011. 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 does not preclude any further regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,

/s/

Steven L. Carter
Director, Compliance Branch
Philadelphia District Office
 

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