January 11, 2018 / 6:39 PM / 8 months ago

BRIEF-FDA Issues Warning Letter To Becton Dickinson & Co

Jan 11 (Reuters) - U.S. Food and Drug Administration:

* FDA WARNS BECTON DICKINSON & COMPANY OF SIGNIFICANT VIOLATIONS OF THE LAW AS PART OF ONGOING INVESTIGATION INTO LEAD TESTING ISSUES‍​

* U.S. FDA SAYS BECTON DICKINSON’S VIOLATIONS INCLUDE MARKETING MODIFIED VERSIONS OF CERTAIN BD VACUTAINER BLOOD COLLECTION TUBES WITHOUT REQUIRED APPROVAL

* FDA SAYS INSPECTION SHOWED BD VIOLATED LAW BY MAKING SIGNIFICANT CHANGE TO SOME OF ITS DEVICES WITHOUT NOTIFYING FDA

* ‍FDA​ SAYS VIOLATIONS WERE DISCOVERED THROUGH AN INSPECTION OF BECTON DICKINSON ‘S NEW JERSEY FACILITY

* FDA SAYS BECTON DICKINSON HAS UNTIL FEB 1, 2018 TO NOTIFY FDA ABOUT SPECIFIC STEPS CO HAS TAKEN TO ADDRESS FDA IDENTIFIED VIOLATIONS

* FDA - BD DID NOT ADDRESS COMPLAINT OF VARIABILITY IN RESULTS WHEN SOME BD VACUTAINER BLOOD COLLECTION TUBES WERE USED WITH MAGELLAN DIAGNOSTICS’ LEADCARE TEST SYSTEMS Source text for Eikon: Further company coverage:

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