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# QS Violations at Tyrx
- URL: https://www.fdaweb.com/qs-violations-at-tyrx/
- Published: 2016-06-21T12:00:00.000Z
- Updated: 2026-09-14T21:10:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135999

A 11/30/15-2/12/16 FDA inspection at Tyrx, Inc., Monmouth Junction, NJ, found Quality System Regulation violations in the firm’s manufacturing of the Tyrx antibacterial envelope, Tyrx antibacterial absorbable envelope, and the Tyrx neuro antibacterial absorbable envelope, according to a 6/2 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506502.htm?ref=fdaweb.com) from the agency’s New Jersey District Office. Specific violations noted on an FDA-483 included: 

- failing to adequately validate according to established procedures a process whose results cannot by fully verified by subsequent inspection and test;
- failing to adequately establish procedures for corrective and preventive action; and
- failing to establish and maintain procedures for changes to a specification, method, process, or procedure where such changes shall be verified or where appropriate validated.

The letter says the firm’s responses to the inspection observations were not adequate. Tyrx was told to take prompt action to correct the violations and prevent their recurrence and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.