Medical Device Maker Philips Medical Systems Gets FDA Warning Letter
April 23rd, 2008 amy
According to a letter released Tuesday, the FDA has warned medical device maker Philips Medical Systems Inc about a long list of manufacturing procedures at the company’s Cleveland Ohio plant, including a failure to properly oversee medical device design.
The FDA’s inspections of the plant, which makes computed tomography (CT) and nuclear medicine devices, in September and October of last year turned up over a dozen production problems. Issues included an “inadequate system to manage production changes and problems with software to check devices,” per the FDA’s letter, which also stated that the company did not properly maintain certain investigative records and failed to set up proper procedures to handle complaints.
The FDA says the company has tried to rectify some of the problems since the 2007 inspections, but that not all of the issues have been resolved to date. Reuters reports that Philips spokesman Arent Jan Hesselink said the company has resolved 10 of the 14 FDA complaints.
