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BRIEF-Philips' subsidiary Philips North America LLC reaches agreement with U.S. DoJ, representing FDA
October 11, 2017 / 5:26 AM / 2 months ago

BRIEF-Philips' subsidiary Philips North America LLC reaches agreement with U.S. DoJ, representing FDA

Oct 11 (Reuters) - KONINKLIJKE PHILIPS NV:

* PHILIPS REACHES AGREEMENT WITH THE U.S. GOVERNMENT ON A CONSENT DECREE FOCUSING ON THE COMPANY’S DEFIBRILLATOR MANUFACTURING IN THE U.S.

* ITS SUBSIDIARY PHILIPS NORTH AMERICA LLC REACHED AGREEMENT ON CONSENT DECREE WITH U.S. DOJ, REPRESENTING FDA‍​

* ‍ANTICIPATES AN EBITA IMPACT OF APPROXIMATELY EUR 20 MILLION IN Q4 OF 2017 AND APPROXIMATELY EUR 60 MILLION IN 2018​

* AGREEMENT ON CONSENT DECREE RELATED TO COMPLIANCE WITH CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS ARISING FROM PAST INSPECTIONS IN AND BEFORE 2015

* DECREE WILL BECOME EFFECTIVE ONCE IT IS APPROVED BY THE U.S. DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS.

* INSPECTIONS IN AND BEFORE 2015 PRIMARILY ON PHILIPS’ ECR BUSINESS OPERATIONS IN ANDOVER (MASSACHUSETTS) AND BOTHELL (WASHINGTON)

* UNDER DECREE, PHILIPS WILL SUSPEND MANUFACTURE AND DISTRIBUTION OF EXTERNAL DEFIBRILLATORS MANUFACTURED AT THESE FACILITIES

* SUSPENSION, SUBJECT TO CERTAIN EXCEPTIONS, UNTIL FDA CERTIFIES FACILITIES’ COMPLIANCE WITH QUALITY SYSTEM REGULATION

* IMPACTS ON EDBITDA RELATE TO SUSPENSION OF PRODUCTION, PROFIT DISGORGEMENT PAYMENTS AND INCREMENTAL COSTS TO PREPARE FOR AND HANDLE THE REGULATORY INSPECTIONS

* AMOUNTS WILL NOT IMPACT ADJUSTED EBITA IN 2017 AND 2018, RESPECTIVELY

* COMBINED SALES OF EXTERNAL DEFIBRILLATOR PRODUCT LINES AFFECTED BY TERMS OF DECREE WAS ABOUT EUR 35 MILLION PER QUARTER IN 2016 Further company coverage: (Gdynia Newsroom)

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