FDA Warns Philips Medical Systems Regarding Manufacturing Procedures at Ohio Plant
by Joan Trombetti, Writer | April 25, 2008
Philips Medical Systems
U.S. health regulators warned Philips Medical Systems, Inc. of a number of problems with manufacturing procedures at an Ohio plant. The problems included a failure to oversee proper device design. This is according to a letter released on April 22.
FDA inspectors visited Philips' Cleveland plant in September and October 2007. At that time, they discovered more than a dozen production problems at the facility that manufactures computed tomography (CT) and nuclear medicine devices.
Other findings included an inadequate system to manage production changes and problems with software to check devices, the FDA said in an April 1, 2008 letter to Philips Medical Systems, a unit of Philips Electronics NV. The letter also said the company did not properly maintain certain investigative records and failed to set up proper procedures to handle complaints.
Since the inspection, Philips Medical has taken some steps to correct the problems but has not addressed all of them, the FDA said.
According to spokesman Arent Jan Hesselink, the company has resolved 10 of the 14 FDA complaints.
He said the company is working on the remaining four and it is a "matter of implementing some changes, in some cases simply a matter of providing the FDA with documentation."
Read FDA warning letters at
http://www.fda.gov/foi/warning.htm
FDA inspectors visited Philips' Cleveland plant in September and October 2007. At that time, they discovered more than a dozen production problems at the facility that manufactures computed tomography (CT) and nuclear medicine devices.
Other findings included an inadequate system to manage production changes and problems with software to check devices, the FDA said in an April 1, 2008 letter to Philips Medical Systems, a unit of Philips Electronics NV. The letter also said the company did not properly maintain certain investigative records and failed to set up proper procedures to handle complaints.
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According to spokesman Arent Jan Hesselink, the company has resolved 10 of the 14 FDA complaints.
He said the company is working on the remaining four and it is a "matter of implementing some changes, in some cases simply a matter of providing the FDA with documentation."
Read FDA warning letters at
http://www.fda.gov/foi/warning.htm
