FDA issues warning letter to Magellan over violations related to blood-lead tests

The FDA issued a warning letter to North Billerica, Mass.-based Magellan Diagnostics after an inspection found the company violated several federal laws with the manufacturing and marketing of its blood-lead testing system.

The violations include marketing significantly altered versions of two blood-lead testing systems without required FDA approval, failing to report discrepancies in test results and neglecting to submit marketing applications for labeling changes that included a revised incubation time.

"The FDA has serious concerns about Magellan Diagnostics' actions after learning about inaccuracies in results using its blood lead testing devices – tests that the American people depend on," said Donald St. Pierre, deputy director of new product evaluation in the FDA's Center for Devices and Radiological Health. "The evidence uncovered during the inspection shows that the company put patients at risk after it recognized that its tests could provide inaccurate results and failed to take appropriate steps to report this issue and work through a strategy to effectively mitigate problems with the FDA. "

Magellan has until Nov. 10 to submit a corrective action plan to the FDA to resolve the violations. Failure to correct the violations could lead to seizure, injunction or civil penalties.  

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