Smith & Nephew Says Business as Usual

British medical devices maker, Smith & Nephew has revealed that it is yet to see any official letter from the US Food and Drug Administration (FDA) regarding the regulator’s unhappiness over one of its production plants in Germany and said that the supply demand will be met regardless of whether there is any problem with the German plant. Share prices of the company fell by almost 2 percent following reports that the FDA has sent it an official letter expressing its concerns over the manufacturing process at its Tuttlingen plant in Germany which manufactures one of its hip replacement devices.

However Smith & Nephew released a statement saying that it had made changes to its procedure when it initially received a letter from FDA back in July and is yet to see the contents of the new letter.

The company went on to say that there will be no problem in meeting the supply demand since it can be manufactured in other plants.

“The FDA raised the issue in July and Smith & Nephew has put in place remedial action. Presumably the FDA is not happy with that remedial action but we do not know what the issue is. The device is also made in Warwick, UK, and Memphis so there is no problem in supply”, a company spokesperson said.




Source-Medindia