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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bacterin International, Inc. - Close Out Letter 9/18/13

  

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

 
 Food and Drug Administration
Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA 98021

Telephone: 425-302-0340
             FAX: 425-302-0402

 

September 18, 2013


OVERNIGHT DELIVERY
SIGNATURE REQUIRED


Darrel L. Holmes
Chief Operating Officer
Bacterin International, Inc.
664 Cruiser Lane
Belgrade, Montana 59714


Dear Mr. Holmes:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 13-11, dated January 28, 2013. 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 will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

 

Sincerely,

/S/

Celeste M. Corcoran, Ph.D.
Acting District Director