FDA 483 - Excite Medical of Tampa Bay LLC - August 25, 2022

An FDA inspection of Excite Medical of Tampa Bay LLC in Tampa, FL, a refurbisher and servicing establishment, revealed two significant observations. The firm was cited for failing to include required information in service reports for its DRX9000 Non-surgical Spinal Decompression Systems. Additionally, the firm's written Medical Device Reporting (MDR) procedures were found to be incomplete, lacking definitions for key terms like "MDR reportable event" and "Serious injury".