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  5. Unomedical s.r.o. - Close Out Letter 7/16/15
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CLOSEOUT LETTER

Unomedical s.r.o.


Unomedical s.r.o.

  

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

Public Health Service
 Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 10993

 

JUL 16 2015
 


VIA UNITED PARCEL SERVICE

Niels Frost-Nielsen
Vice President
Unomedical s.r.o.
Priemyselny Park 3
07101 Michalovce
Slovakia

Dear Mr. Frost-Nielsen:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #428938, dated May 28, 2014. Based on our evaluation, it appears that you have addressed the violations contained in the 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 yours,

/S/

Carl Fischer, Ph.D.
Director
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health