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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tytex Slovakia S.R.O. - Close Out Letter 7/18/14

  

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 20993

 

JUL 18, 2014


Steen A Henriksen
Vice President of Operations
Tytex Slovakia S.R.O.
Chemlonska 1
06601 Humenne
Slovakia (Slovak Republic)


Dear Mr. Henriksen:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter issued on June 12, 2013. Based on our evaluation, it appears that your firm has 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 yours,

/S/

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

 

cc.

US Agent
Sharon Blinkoff
Edwards Wildman Palmer LLP
750 Lexington Avenue
New York, NY 10022
e-mail: SBlinkoff@edwardswildman.com