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# QS Violations Found at Sure Tek Medical
- URL: https://www.fdaweb.com/qs-violations-found-at-sure-tek-medical/
- Published: 2016-03-15T12:00:00.000Z
- Updated: 2026-09-15T02:44:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135076

> A 10/26-11/10/15 FDA inspection at Sure Tek Medical, Greenville, SC, found Quality System Regulation violations in the firm’s manufacturing of medical devices such as orthopedic and laparoscopic instruments. A 3/3 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm489979.htm?ref=fdaweb.com) from the agency’s Atlanta District Office says that procedures for monitoring and control of process parameters for a validated process have not been established and gives them examples of this violation.  
>  
> The letter acknowledges corrective actions the firm has implemented and says that they appear to adequately address the observations identified on the FDA-483.  
>  
> Sure Tek 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.