FDA Still Has Problems With Schering-Plough Plants - TheStreet

FDA Still Has Problems With Schering-Plough Plants

Follow-up inspections of the drugmaker's plants in New Jersey and Puerto Rico reveal continuing deficiencies.
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continues to have trouble getting its act together.


finding problems with the drugmaker's manufacturing processes in February, the

Food and Drug Administration

returned to the company's New Jersey and Puerto Rico plants in May and June for a follow-up inspection. This morning, Schering-Plough said the FDA still found that the company wasn't in compliance with good manufacturing practices. The company is working to address the problem.

In May, Schering-Plough presented a plan for fixing the problem to the FDA, but those efforts, which included changes to the company's corporate structure and more funds to combat the deficiencies, apparently weren't effective enough.

Some damage already has been done as a result. Federal approval for Clarinex, Schering-Plough's next-generation version of cash-cow allergy fighter Claritin, has been delayed. Schering said it couldn't predict the outcome of these issues or tell when they would be resolved.