Washington Devicemaker Hit for Preventative Maintenance Violations
The FDA cited Fabtech Precision Manufacturing for its lack of preventative maintenance documentation at its Spokane Valley, Washington facility, issuing the firm a Form 483.
During a March 4-8 inspection of the facility, the FDA that the firm’s preventative maintenance records did not include all the required information. The agency found that four records did not contain the device number, serial number and location information.
The agency noted that preventative maintenance records are required to detail certain information at a minimum, including the device’s model number, serial number, manufacturer, type, location, preventative maintenance tasks required and the frequency of each task.