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"We are pleased that the Chiron Corporation has taken steps to address issues at their facility in Liverpool as they prepare for the upcoming flu season," said Dr. Jesse Goodman, FDA Director of the Center for Biologics Evaluation and Research. "The letter that we issued to them this week is a positive development and shows significant progress on their part. However, additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season. FDA will evaluate the implementation and effectiveness of their corrective actions going forward. In addition, any vaccine produced must pass all tests for safety and potency before it can be marketed in the U.S."
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