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Home » OrthoGroup Gets 483 for Incomplete Device History Records, Missing CAPAs
OrthoGroup Gets 483 for Incomplete Device History Records, Missing CAPAs
OrthoGroup was handed a Form 483 after an inspection of its Rancho Cordova, Calif., facility found incomplete device history records (DHR), missing corrective and preventive action (CAPA) records and multiple procedures not being followed.