FDA states in their close out letter dated Feb. 11, 2015 that the company successfully performed corrective and preventive actions and that the violations contained in the 2012 warning letter have been addressed. According to Siegfried, the resolution of the warning letter allows for the full integration of Hameln Pharma into the Siegfried Group, and American customers are now able to import products from the Hameln facility to the US.
“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,” said Siegfried CEO Rudolf Hanko, in a press release.
Source: Siegfried Group
