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# QS Issues Found at Terumo Medical
- URL: https://www.fdaweb.com/qs-issues-found-at-terumo-medical/
- Published: 2016-03-22T12:00:00.000Z
- Updated: 2026-09-14T20:50:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135150

> A 10/19-10/23/15 FDA inspection at the Terumo Medical Corp. facility in Elkton, MD, found Quality System Regulation violations in the firm’s manufacturing of destination guiding sheaths for renal, carotid, and peripheral use. A 3/17 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm491287.htm?ref=fdaweb.com) from the agency’s Baltimore District Office says that violations included:  
> failing to establish and maintain procedures to control nonconforming product; failing to establish and maintain procedures that define the responsibility for review and the authority for disposition of nonconforming product; failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications; failing to establish and maintain procedures for verifying the device design; failing to establish and maintain procedures for validating the device design; failing to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures; and failing to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.  
>  
> The letter says the firm’s responses were inadequate or their adequacy could not be determined. Terumo 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.