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Medical Devices / Inspections and Audits

Failure to Document OOS Results Lands Symmetry Medical 483

Nov. 27, 2018
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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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