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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Encompass Group, LLC - Close Out Letter 9/18/12

  

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

September 18, 2012


Michael Spurlock, CEO
Encompass Group, LLC
615 Macon Road
McDonough, Georgia 30253

Dear Mr. Spurlock:

The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 2012-NOL-07 dated December 27, 2011. 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 FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter does not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,

/S/

Kari L. Batey
Acting Compliance Branch Director
New Orleans District

 

 

 

cc: Patrick F. Frank
     Quality Value Relationship Manager
     Albahealth, LLC
     425 North Gateway Boulevard
     Rockwood, Tennessee 3 7854