Thermo Fisher Inspection Finds Poor Custom Device Procedures

December 13, 2010
Thermo Fisher Scientific received a Form 483 for its handling of custom orders of Class II devices. The Marietta, Ohio, company gives the custom devices model numbers that are not listed as Class II devices, but it doesn’t ensure the devices are not used in Class II applications, according to the form. It also does not verify or validate custom changes. Additionally, FDA inspectors found the company’s finished product testing for Class II devices is inadequate.
The GMP Letter