www.fdanews.com/articles/188695-transamerican-technologies-snagged-for-device-history-records
Transamerican Technologies Snagged for Device History Records
October 5, 2018
Transamerican Technologies, a devicemaker based in San Ramon, California, received a Form 483 for insufficiently maintaining its device history records (DHR).
Specifically, all 11 of the firm’s DHRs — which it referred to as “production work orders” — didn’t include or refer to the primary identification label’s location and the labeling used for each device.
One of the firm’s laser systems — found on the floor and out of the box — also lacked a label or tag showing the standards to which it conforms.