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Medical Devices / Inspections and Audits

Failure to Document OOS Results Lands Symmetry Medical 483

Nov. 27, 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.

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