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# Quality System Violations in Clinicon Inspection
- URL: https://www.fdaweb.com/quality-system-violations-in-clinicon-inspection/
- Published: 2019-07-09T12:00:00.000Z
- Updated: 2026-09-15T01:36:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144485

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](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/clinicon-corp-582801-06202019?ref=fdaweb.com) 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.