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  5. Edge Biologicals, Inc. - Close Out Letter 3/25/15
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CLOSEOUT LETTER

Edge Biologicals, Inc.


Edge Biologicals, Inc.

  

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

 
 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

 

March 25, 2015


 


Walter C. Edge, Owner/President
Edge Biologicals, Inc.
598 North Second Street
Memphis, Tennessee 38105-1634


Dear Mr. Edge:

The Food and Drug Administration completed an evaluation of your firm’s corrective actions in response to Warning Letter No. 2012-NOL-13, dated February 14, 2012. 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/

Mark W. Rivero
Acting Director Compliance Branch
New Orleans District