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CLOSEOUT LETTER

Epflex Feinwerktechnik GmbH Jul 16, 2015

Epflex Feinwerktechnik GmbH - Close Out Letter 7/16/15


Epflex Feinwerktechnik GmbH

  

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 16 2015

Bernhard Uihlein
Managing Director, Owner
Epflex Feinwerktechnik GmbH
Vogelsangstrasse 60
72581 Dettingen an der Erms
GERMANY

Dear Mr. Uihlein:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to the Warning Letter dated September 16, 2013. Based on the Agency's 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 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 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/

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