The FDA issued a warning letter to Becton Dickinson & Co. (NYSE:BDX) today, citing a number of violations of federal law that it identified in an inspection of the company’s New Jersey facility.
The inspection, which was done as part of the agency’s ongoing investigation into the cause of inaccurate blood lead tests linked to Magellen Diagnostics, showed that BD marketed a significantly-modified version of its Vacutainer blood collection tube without FDA clearance or approval.