FDA Warning Flu Vaccine Maker

The Food and Drug Administration issued a warning letter to drug maker Sanofi Pasteur over concerns about problems at a Pennsylvania manufacturing plant, the agency said Monday.

Sanofi Pasteur had reported that some batches of its influenza vaccine failed sterility tests in April, prompting an FDA inspection of the plant in Swiftwater, Pa.

None of the affected material was used in making vaccine and no further problems have occurred, FDA said.

But the agency said it was issuing the warning letter because the source of the contamination has not been determined, meaning it cannot be sure the problem has been corrected.

The letter is an advisory action and the plant can continue making vaccine, said Dr. Karen Midthun, deputy director of the FDA's Center for Biologics Evaluation and Research.

Sanofi Pasteur issued a statement saying it is working closely with FDA and many of the agency's concerns "have either been resolved or the FDA has accepted our proposed remediation plans."

The company added: "With regard to the upcoming influenza season, we are confident that we will meet our manufacturing goal of approximately 50 million doses of influenza vaccine for the U.S. market."

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Food and Drug Administration: http://www.fda.gov