![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Cites California Firm for Documentation
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.
Upcoming Events
-
18Jul
-
21Oct