www.fdanews.com/articles/189299-failure-to-document-oos-results-lands-symmetry-medical-483
![RedWarningStamp.gif](https://www.fdanews.com/ext/resources/test/Device_Images5/RedWarningStamp.gif?t=1576044606&width=430)
Failure to Document OOS Results Lands Symmetry Medical 483
November 26, 2018
Surgical instrument and orthopedic implant manufacturer Symmetry Medical found itself in hot water with the FDA, following a Sept. 5 to Sept. 10 inspection of its Claypool, Indiana facility that landed it a Form 483.
An investigation of an out-of-tolerance gage was not documented, and corrective actions were not initiated for non-conforming material, the agency said.
An identification of potentially affected product was missing in the quality alert notifications for the gage, the FDA said.