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CLOSEOUT LETTER

FSSB Chirurgische Nadeln Gmbh Aug 06, 2015

FSSB Chirurgische Nadeln Gmbh - Close Out Letter 8/6/15


FSSB Chirurgische Nadeln 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

AUG 6 2015

Mr. Henry Frenzel
CEO
FSSB Chirurgische Nadeln GmbH
Allmendweg 2
79798 Jestetten
Germany

Dear Mr. Frenzel:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS #390140, dated January 29, 2013. Based on our evaluation, it appears that 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/

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