FDA 483 - B-ONE ORTHO, CORP. - May 18, 2022

An FDA inspection of B-ONE ORTHO, CORP. in Cedar Knolls, NJ, revealed inadequate procedures for corrective and preventive action. The firm failed to initiate corrective actions for nonconforming events related to its Mobio® Knee Implant system, where components were manufactured or certified to incorrect revision levels. This indicates a significant lapse in their quality system regarding product conformity.