Denttio Draws Warning for Complaint Evaluations, CAPA
Denttio’s Los Angeles, Calif., facility was hit with a warning letter for inadequate complaint evaluations and CAPA procedures.
In an August 2016 inspection, inspectors noted the facility lacked procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. For example, it failed to investigate 19 complaint records for its digital X-ray sensors for medical device reporting.
The firm also failed to document an investigation for three CAPA records, and two records reported as closed did not include verification or validation of the corrective actions.