Expects to reach an agreement soon with the US FDA over quality management in its Medical Systems business
Swedish medical technology group Getinge said it expects to reach a deal soon with the US Food and Drug Administration over quality management in its Medical Systems business, which is costing it about SEK500m (US$61m) in operating profit.
The company said 2014 was a 'challenging year' as it increased net sales by 5.5% to SEK26.7bn and pre-tax profit fell by 36.9% to SEK1.4bn.
Medical Systems and Infection Control displayed a positive trend year-on-year, reporting sales increases of 4.3% and 6%, respectively.
Getinge said the weak earnings trend was primarily the result of low volume growth in emerging markets and a number of delayed deliveries. The company also saw delivery disruptions in the Cardiovascular division of the Medical Systems group caused by measures currently being carried out on its quality management system following FDA inspections in 2013.
The company says the cost of these measures will now amount to SEK995m. The total remediation programme is expected to be completed by mid-2016.
Getinge is currently restructuring its Cardiovascular division with the aim of enhancing the production of vascular implants, which will mean cutting the manufacture of textile-based products from two plants to one, in La Ciotat, France. The move to La Ciotat is expected to be completed in the second quarter of 2015.