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FDA Issues Warning to Sanofi Pasteur Flu Vaccine Plant

Swiftwater, Penn., facility failed to maintain sterile production conditions

THURSDAY, July 6 (HealthDay News) -- The U.S. Food and Drug Administration has issued a warning letter to Sanofi Pasteur, Inc., in Swiftwater, Penn., on the basis of inspections conducted in April this year that revealed several significant failures to maintain current good manufacturing practices.

The warning applied to the company's manufacture of licensed biological products and Fluzone monovalent concentrate batches. The visit to Sanofi Pasteur's Swiftwater facility was the second such inspection since annual checks of vaccine manufacturers were instituted after compliance issues were discovered at Chiron's vaccine manufacturing plant in 2004.

The inspections revealed suboptimal conditions in the manufacture of monovalent concentrates that resulted in several batches failing sterility tests. There were also significant problems with the company's good manufacturing practices for its finished products. Several of the problems were identified in a March 2005 FDA inspection but the company did not take adequate steps to correct them prior to the 2006 inspection.

The problems noted during the FDA inspection are not expected to cause disruption to the company's supply of vaccines for the 2006-2007 flu season and the sterility problems do not mean that Sanofi Pasteur's vaccines are contaminated.

"The sterility problems occurred in monovalent concentrates, not in the final vaccine product. The failed monovalents represented a small number of the total number of monovalents produced and were rejected by the firm and not used for further processing," according to an FDA statement regarding the warning letter.

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