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FDA Accuses Scope Makers Of Flouting Safety Studies

Law360 (March 9, 2018, 8:35 PM EST) -- The U.S. Food and Drug Administration fired off warning letters Friday to three medical scope makers implicated in a major outbreak of “superbug” infections, accusing them of shirking commitments to conduct safety studies.

The warning letters went to Fujifilm Medical Systems USA Inc., Olympus Medical Systems Corp. and Pentax of America Inc. The companies are the primary manufacturers of duodenoscopes that were linked in 2015 to serious bacterial infections, a result of the scopes being reused and difficult to sterilize.

All three companies have, to varying...
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