Trinity Biotech Hit for Insufficient Device History Records
Primus Corporation, doing business as Trinity Biotech, was cited by the FDA in a Form 483 for unsatisfactory device history records observed at its Kansas City, Missouri facility.
The firm lacked a procedure to ensure that its device history records included, or noted the location of, the primary identification label or labeling.
Specifically, device history records for two of the firm’s Class II medical devices didn’t include or refer to the location of their primary identification labels and labeling for each unit. The operator’s manual shipped with the products also were not adequately documented in the device history record.