FDA 483 - Spinergy, Inc (SM Power LLC) - August 15, 2023

An FDA inspection of Spinergy, Inc (SM Power LLC), a Class II medical device manufacturer in San Marcos, CA, revealed significant deficiencies in their quality system. Observations included a lack of written Medical Device Reporting (MDR) procedures, inadequate equipment calibration, and insufficient documentation for corrective and preventive actions. Additionally, device history records were found to be incomplete, failing to meet device master record requirements.