Noven Pharmaceuticalshas received a close-out letter from the FDA lifting a 2016 Warning Letter related to its Miami, Florida manufacturing facility. The FDA notice follows a reinspection earlier this year by the FDA of Noven’s Miami facility.
The lifting of the Warning Letter is the result of a comprehensive remediation program that not only addressed the issues raised by FDA in the 2016 Warning Letter, but included the assessment and remediation of all aspects of Noven’s quality systems to ensure alignment with current Good Manufacturing Practices.
“For more than two years now, we have been focused on creating a robust and sustainable quality program based on a culture of quality, accountability across the entire organization and the continuous improvement of our people, processes and products,” said Jeff Mihm, Noven chief executive officer.
“Noven’s enhanced quality program provides a strong foundation for our plans to bring new transdermal products to patients in the United States and abroad,” Mr. Mihm added. Noven currently manufactures and sells three transdermal products in the United States, and together with its Japanese parent company, Hisamitsu Pharmaceutical Co., Inc., has several new transdermal products in mid- to late-stage development.
(Source: Noven Pharmaceuticals, Inc.)
