U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Ebewe Pharma Ges MBH Nfg KG - Close Out Letter 9/14/15
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Ebewe Pharma Ges MBH Nfg KG


Ebewe Pharma Ges MBH Nfg KG

  

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

Public Health Service
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
 Office of Manufacturing Quality
Division of Drug Quality I
Global Compliance Branch 2
10903 New Hampshire Avenue
Building #51, Room 4235
Silver Spring, MD 20993

TELEPHONE: (301) 796-5339
              FAX: (301) 847-8742

September 14, 2015

Mr. George Kahwati
General Manager
EBEWE Pharma Ges.m.b.H.Nfg.KG
Mondseestrasse 11
A-4866 Unterach am Attersee
Austria


Reference: FEI 3002829723

Dear Mr. Kahwati:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 320-13-19 dated May 28, 2013. Based on our evaluation, it appears that you have addressed the violation(s) 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 or 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 or compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

If you have any questions regarding this letter, you may contact me at the above address or number.


Sincerely,

/S/

Cesar E. Matto, MS
Senior Policy Advisor
Division of Drug Quality I