Wednesday, September 9, 2009

K-V Pharma: FDA Accepts Plan to Resolve Manufacturing Issue

Reuters on September 2nd reported that K-V Pharma has announced that the U.S. Food and Drug Administration had accepted its work plan to address previously identified deficiencies in its manufacturing practices. In March, the U.S. Department of Justice sued the drugmaker to block it from making and distributing adulterated and unapproved drugs, after an inspection by the FDA found the company had violated manufacturing guidelines and continued to manufacture unapproved drugs.

K-V Pharma has begun implementing certain measures set forth in the work plan but does not expect to resume product shipments before the third quarter of fiscal 2010, it said in a filing with the U.S. Securities and Exchange Commission on Wednesday.

The drugmaker said it anticipates it will request Lachman Consultants, its independent current good manufacturing practices (cGMP) expert, to conduct its certification review later this calendar year.

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