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Home Industry News Schering-Plough meets consent decree deadline

Schering-Plough meets consent decree deadline

4th January 2006

Schering-Plough has announced that it met a deadline set by the US Food and Drink Administration (FDA) to prove its facilities meet necessary standards.

The company announced that the 212 significant steps and 30 validation actions required by December 31st 2005 under the agency’s consent decree were completed.

Schering-Plough chairman and CEO Fred Hassan said: “The timely completion of our cGMP [current Good Manufacturing Practices] Work Plan and Validation Certification Programme represents another significant milestone as we work to build the New Schering-Plough.

“Many Schering-Plough colleagues worked tirelessly and with a sustained focus to achieve this important goal. We remain committed to continuing our quality and compliance programs and look forward to the time when we can request that the consent decree be lifted.”

The FDA had ordered the upgrades together with a $500 million fine in May 2002 after the company’s sites in New Jersey and Puerto Rico came in for criticism.

The improvements still need to be reviewed by a third party before FDA approval and the company was unable to gauge how long this would take.

track© Adfero Ltd

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