In addition, thismisconductresults in severeconsequences, such as grade-related penalties, suspension, or an adversedisciplinaryrecordthatmayvery well impactfutureopportunities and so on.
"We have had a tough year, impacted by unfavourable foreign exchange, recordadverse weather in the UK and declining underlying markets in each of our three key territories, " he said.
In addition to the defect, first identified in 2007, the FDA criticizes the device manufacturer for failing to record and investigate multiple complaints about adverse events resulting from use of the pump.