NuVasive, Inc – FDA 483, May 4, 2017

An FDA inspection of NuVasive, Inc. in Memphis, TN, a medical device manufacturer, revealed significant deficiencies in their quality management system. Observations included inadequate establishment and implementation of corrective and preventive action procedures, and insufficient control over nonconforming products. Additionally, the firm failed to provide justification for not reporting certain correction or removal actions to the FDA.