Quality System Violations in Clinicon Inspection

A 4/3-4/4 FDA inspection at Clinicon Corp., Oceanside, CA, found Quality System Regulation violations in the firm’s work as a manufacturer (specification developer) of the SureProbe Class 2 sterile, single-use, laser accessory probes, among other devices. A 6/20 Warning Letter says specific violations were: 

•          failing to adequately document and approve process validation activities and results;
•          failing to document equipment calibrations, inspections, checks, and maintenance activities;
•          failing to document evaluation of potential suppliers and contractors; and
•          failing to maintain a device history record.

Clinicon was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, documentation of the corrections and corrective actions, and a schedule for completion.