Pennsylvania Firm Cited for Laser Marker
The FDA slapped Quakertown, Pennsylvania devicemaker Wilsey Tool Company with a Form 483 for problems related to its laser marker.
An agency inspection revealed a lack of validation studies for the laser etching process used by its laser marker, which the firm used to engrave lot numbers on implantable devices and orthopedic tools. This included testing to see if the process caused adverse effects on devices such as post-processing metal fatigue and corrosion.
The firm was also called out for having no calibration or maintenance schedule for a laser marker used to etch device components and parts.