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