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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pioneer Surgical Technology, Inc. - Close Out Letter 7/17/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

JUL 17, 2012


Mr. Daniel Webber
President and CEO
Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette, Ml 49855 

Dear Mr. Webber:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated August 3, 2010. Based on our evaluation, it appears that your firm has addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will assess the adequacy and maintenance of these corrections.

This letter does not relieve your firm of its responsibility to take all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations, as well as other relevant legal authority. The FDA will continue to monitor your firm's state of compliance and this letter will not preclude future regulatory action should violations be observed through inspection or other means.

Sincerely yours, 

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health Chief