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CLOSEOUT LETTER

Hameln Pharmaceuticals Gmbh


Hameln Pharmaceuticals Gmbh

  

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 4212
Silver Spring, MD 20993

TELEPHONE: (301) 796-3916
              FAX: (301) 847-8742

February 11, 2015

Torsten Fӧrster
Managing Director
Hameln Pharmaceuticals Gmbh
Langes Feld 13
Hameln - 31789
Germany


Reference: FEI 3002807877


Dear Mr. Fӧrsten:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter WL: 320-13-06 dated December 17, 2012. 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/

Maan Abduldayem
Compliance Officer
Division of Drug Quality I