FDA 483 - Nevro Corporation - August 13, 2025

Nevro Corporation, a medical device manufacturer in Redwood City, CA, was inspected and received a Form FDA-483 with six observations. The inspection revealed significant deficiencies in process validation for re-boxing, inadequate complaint handling and investigation, uncontrolled production processes for packaging, and insufficient design validation for packaging. Additionally, the firm failed to submit Medical Device Reports (MDRs) within the required timeframe and lacked adequate documentation for corrective and preventive actions.