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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bass Medical Inc - Close Out Letter 08/28/2012

  

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

Public Health Service
Food and Drug Administration
 

New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217


Telephone: (615) 366-7801
         FAX: (615) 366-7802

 

 

August 28, 2012


Julie A. Ryan, President
Bass Medical, Inc.
2539 John Hawkins Parkway, Suite 101
Birmingham, Alabama 35244


Dear Ms. Ryan:


The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 2009-NOL-03, dated February 12, 2009. Based on our evaluation, it appears 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 will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,

/S/

Ruth P. Dixon
Director
Compliance Branch
New Orleans District