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LEDERLE PERTUSSIS VACCINE SUPPLIER TAKEDA CITED BY FDA

Executive Summary

LEDERLE PERTUSSIS VACCINE SUPPLIER TAKEDA CITED BY FDA for failure to obtain agency approval before instituting a change in manufacturing methods, a June 23 FDA warning letter to Takeda's Osaka, Japan office states. Takeda, which supplies the acellular pertussis component of Lederle-Praxis' diphtheria, tetanus and pertussis vaccine Acel-Immune, did not "receive notification from the Center for Biologics Evaluation & Research of acceptance of a change in manufacturing methods" before changing the building in which sterility testing for the product is performed, FDA said.

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