FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Transamerican Technologies Snagged for Device History Records

Oct. 8, 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.

View today's stories