Schering-Plough, FDA Reach Agreement

Schering-Plough Corp. announced an agreement with federal regulators on a plan to rectify manufacturing deficiencies that led to a record $500-million fine a year ago.

The Kenilworth, N.J.-based maker of allergy, respiratory and hepatitis C medications said in a filing with the Securities and Exchange Commission that the Food and Drug Administration had concurred May 14 with the company’s plans to bring four manufacturing plants in compliance with FDA standards.

The FDA had found significant, repeated and widespread violations “related to facilities, manufacturing, quality assurance, equipment, laboratories and packaging and labeling,” the agency said in May 2002.

Schering-Plough shares rose 10 cents to $18.28 on the New York Stock Exchange.

From Associated Press