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Michelle Hoffman, editorial director of Pharmaceutical Technology.
Schering-Plough announced today that a consent decree filed against the company in May, 2002, had been dissolved by the US District Court for the District of New Jersey in Newark.
Kenilworth, NJ (Aug. 2)-Schering-Plough announced today that a consent decree filed against the company in May 2002, had been dissolved by the US District Court for the District of New Jersey in Newark. The consent decree of permanent injunction enjoined the company from manufacturing, packaging, or distributing some 42 products in its Kenilworth and Union, New Jersey, plants and another 13 products in its plants in Manati and Las Piedras, Puerto Rico, because of violations of US Food and Drug Administration’s good manufacturing practices. The company, then under the direction of CEO Richard J. Kogan, was also directed to recall and destroy all lots of Theophylline and Proventil Repetabs in the United States that were still within their labeled expiration periods. Finally, the government levied stiff fines against the company totaling $500 million.
On January 3, 2006, the company announced it had completed all of the 212 significant steps and the 30 validation actions set out by the decree. At the time, the company petitioned the government to dissolve the decree and allow them to reopen the plants.
In a statement issued through a company press release, Fred Hassan, Schering-Plough’s chairman and CEO responded to the dissolution by saying, “This is an important milestone for Schering-Plough as we continue to put issues of the past behind us and make further progress on our Action Agenda. Schering-Plough colleagues have worked hard to establish continuous quality improvement and compliance as part of our culture. In turn, we have been working diligently to earn the trust of our stakeholders. Ensuring quality in our products and systems underpins everything we do.”