FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues
Today the U.S. Food and Drug Administration issued a warning letter to Magellan Diagnostics Inc. for several violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results. Continue reading.
DRUG REGULATORY AFFAIRS INTERNATIONAL 