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RESPONSE LETTER

Merge Healthcare


Company:
Merge Healthcare

MERGE

350 N. Orleans Street, 1st Floor
Chicago, IL  60654
P: 312-565-6868
F: 312-565-6870

www.merge.com

 

January 23, 2015
 
Rebecca A. Asente M.S., R.D.
Compliance Officer
U.S. Food and Drug Administration
New Orleans District
Metairie Resident Post, Metairie Center
2424 Edenborn Avenue, Suite 410
Metairie, LA 70001
 
RE: Warning Letter No. 2012-NOL-28, dated August 24, 2012
 
Dear Ms. Asente,
 
When Warning Letter No. 2012-NOL-28 was issued following an FDA inspection of the facility located at 511 Creasman Drive, Winchester, Tennessee, Merge Healthcare took immediate steps to initiate and implement appropriate corrective actions. A subsequent inspection performed in February, 2013 indicated that satisfactory progress had been made towards addressing the FDA’s observations. All of the planned corrective actions have since been completed and await the FDA’s final confirmation.
 
We wish to notify you that Merge Healthcare has sold all of its assets related to the health station kiosk business and no longer manufactures or markets blood pressure monitoring computer kiosks.
 
Please contact Carol Nakagawa, Director, Quality & Regulatory Affairs, at 905.364.8027, if you have any questions.
 
We respectfully request that this letter be posted on the FDA website.
 
Sincerely,
/s/ 
Justin Dearborn, CEO
Merge Healthcare Incorporated
 
cc: Michael Diedrick, VP Quality & Regulatory Affairs
Carol Nakagawa, Director, Regulatory Affairs