Siegfried: Revocation of FDA warning letter
Siegfried announces comprehensive solution for the Hameln facility's regulatory issues
The sterile filling production facility in Hameln acquired by Siegfried in November 2014 as per public knowledge had previously been issued a warning letter by the FDA. End of last week the FDA revoked the warning letter and declared Hameln’s production to be in accordance with all regulatory requirements.
In 2012, the FDA issued a warning letter to Hameln Pharma. Siegfried provided support to the company in compliance matters prior to the acquisition. Now, following revocation of the warning letter, the path has been cleared for the Hameln Pharma facility to be immediately and fully integrated into the Siegfried Group’s worldwide compliance system. The warning letter revocation also permits an American customer to import its product to the USA. The German regulatory authorities have recently confirmed renewal of Hameln’s GMP certificate required in regular intervals.
Siegfried CEO Rudolf Hanko: “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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