Home » FDA Cites California Firm for Documentation
FDA Cites California Firm for Documentation
December 9, 2019
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.
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