Philips' Profit To Be Dented By FDA-Decreed AED Sales Halt
Executive Summary
On signing a consent decree with the US FDA, Philips is halting manufacture and sales of external defibrillators produced at two facilities until the agency is satisfied the company is complying with current good manufacturing practice requirements. The suspension is expected to impact Philips' EBITA for the fourth quarter 2017 and for 2018.
You may also be interested in...
Repeated Quality Systems Issues Bring Philips Consent Decree
After two warning letters, eight inspections, and quality systems concerns dating to 2009, the government has largely blocked Philips Healthcare from manufacturing automated external defibrillators and similar products made at two of the company's facilities until the concerns are resolved.
Could Alcon's CyPass Trouble Be Boon For Glaukos – Or Bust For MIGS?
Minimally invasive glaucoma surgery specialist Glaukos saw its stock leap 40% in the wake of a worldwide recall by much bigger rival Alcon of its CyPass microstent.
Roche Dx' EMEA Head To Take Charge After Diggelmann Departs
Roland Diggelmann will end his decade-long career at Roche Diagnostics at the end of September. The business's head of EMEA Michael Heuer will take Diggelmann's place while the search is on for his replacement.