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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 sy...

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