FDA Cites California Firm for Documentation

The FDA hit Clinicon with a Form 483 for a  lack of documentation at its Oceanside, California facility.

The Class II devicemaker was written up for multiple violations, including a failure to document equipment calibrations, inspections and maintenance activities.

The company’s standard operating procedure required it to calibrate test equipment, but no calibration or maintenance activities were on file for a heat sealer used to close and package its laser probe accessory, which was subject to ethylene oxide sterilization at a contract sterilizer.