FDA reported contamination concerns at Merck vaccine plant
Based on an unpublished study, the Food and Drug Administration found potentially serious problems at Merck & Co.’s plant located in the Philadelphia suburbs. Contaminated children’s vaccines were among the 49 concerns cited by the federal regulators ranging from failure to follow good management practices to contamination of bulk lots of vaccine. Inspectors from the FDA visited the Merck plant between November 2007 and January 2008. In December, Merck recalled 1.2 million doses of its vaccine against Haemphilus influenza type B because of a sterility problem discovered in October and quarantined almost a year’s worth of other suspected doses. At this time the FDA has not ordered the plant to stop production while reviewing Merck’s responses to their report.
