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# Innovative Sterilization QS Issues
- URL: https://www.fdaweb.com/innovative-sterilization-qs-issues/
- Published: 2016-03-15T12:00:00.000Z
- Updated: 2026-09-15T02:43:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135077

> An 8/4-8/13/15 and 10/6-11/4/15 FDA inspection at Innovative Sterilization Technologies, Dayton, OH, found Quality System Regulation violations in the firm’s work as the specification developer of the One Tray sealed sterilization container. A 3/2 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm489358.htm?ref=fdaweb.com) from the agency’s Cincinnati District Office says that specific violations noted on an FDA-483 included:  
> failing to establish and maintain procedures for implementing corrective and preventive actions; failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met; failing to establish and maintain adequate procedures for receiving, reviewing, evaluating, and investigating complaints by a formally designated unit; failing to establish and maintain procedures for changes to a specification, process, or procedures; and failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.  
>  
> The letter also says that the firm failed or refused to furnish material or information about the device that is required under the reports of correction and removals regulation.  
>  
> Innovative was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.