Takeda Warned By FDA Over Manufacturing Practices

The US Food and Drug Administration has issued a warning letter to Takeda over its failure to obtain regulatory approval before instituting a change in manufacturing methods related to supplies of the acellular pertussis component of Lederle-Praxis' diptheria/tetanus/pertussis vaccine Acel-Imune. The FDA says that the company had not "received notification from the Center for Biologics Evaluation & Research of acceptance of a change in manufacturing methods before changing the building in which sterility for the product is performed."

The sterility testing change is among 10 Good Manufacturing Practices violations listed in the letter, most of which involve record keeping. The letter resulted from the FDA's inspection of the company's facility in April.

Lederle responded that Takeda is working closely and cooperatively with the FDA on the remaining issues, and that the observations will have no impact on the importation of the pertussis component or the manufacture of the vaccine.