Failure to establish a design history file or to put procedures in place to control device history records, in addition to failure to conduct quality reviews, landed devicemaker LSVT Global a 10-item Form 483 following a July 16 to July 17 inspection of is plant in Tucson, Arizona.
The firm’s companion diagnostic software device with a microphone for evaluating patients with Parkinson’s disease for loudness and communication that has been on the market since September 2009, but it had not established a design history file, the FDA said.
The device software, which was developed by a third party software developer, was not validated, and LSVT lacked a device master record and a documented risk analysis plan for its unclassified companion device.
The firm failed to put procedures in place for controlling device history records, nor did it maintain or document device history records for batch/unit release of the device.
Potential suppliers of the software, microphone and USB used in manufacturing the companion device were not evaluated, the 483 says, and procedures for acceptance of incoming products were not established.
The FDA said the firm had not conducted any quality system management reviews since the business began in 2003, and management with executive responsibility had not reviewed the suitability of the quality system. Not surprisingly, no quality audits had been conducted since the firm was established, and there was no documentation for personnel training.
Read the LSVT Global Form 483 here: www.fdanews.com/10-30-18-lsvtgloballlc483.pdf.