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FDA Revokes Warning Letter for Hameln Facility

Sterile fill production facility found in accordance with regulatory requirements

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By: Kristin Brooks

Managing Editor, Contract Pharma

The FDA has revoked the warning letter issued to Hameln Pharma’s sterile filling production facility in Hameln, Germany, which Siegfried acquired in November 2014, declaring production to be in accordance with all regulatory requirements.  
 
The FDA issued the warning letter to Hameln Pharma back in 2012. Siegfried had provided support to resolve compliance issues prior to the acquisition. The Hameln Pharma facility will now be fully integrated into the Siegfried Group’s worldwide compliance system. The revocation allows American customers to import its product to the U.S. The German regulatory authorities have also recently confirmed renewal of Hameln’s GMP certificate.
 
Rudolf Hanko, Siegfried’s chief executive officer said, “This is an announcement which our American customers, especially, have been waiting for. Revocation of the warning letter is the result of joint efforts. It represents a significant step in Hameln’s ongoing integration process into the Siegfried Group.

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