FDAnews Drug Daily Bulletin

SCHERING-PLOUGH TO CLOSE PLANT, MAKE MAJOR JOB CUTS

June 12, 2006
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New Jersey-based Schering-Plough is phasing out manufacturing operations at its Manati, Puerto Rico site by the end of 2006, the company announced. In addition, the company will lay off 1,000 workers at its facilities in Puerto Rico and New Jersey.

The company will discontinue approximately 600 positions in Puerto Rico alone, including approximately 550 in Manati and 50 in Las Piedras. Five hundred full-time positions will also be eliminated in New Jersey at the company's Kenilworth and Union sites.

The decision to reorganize comes five months after Schering-Plough completed 212 significant steps and 30 validation actions to resolve major cGMP deficiencies at its New Jersey and Puerto Rico facilities. The original current good manufacturing practice (cGMP) overhaul request was made by the FDA in 2002, via a consent decree, with a deadline of December 2005. The company completed these manufacturing fixes -- which included revalidating both finished drugs and bulk active ingredients made at four plants -- in early January of this year.