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

During an FDA inspection conducted from August 14-15, 2023, Spinergy, Inc (SM Power LLC), a Class II medical device manufacturer, received a Form FDA 483 outlining four significant observations. The inspection revealed deficiencies in the company's quality management system, critical for compliance with federal regulations governing medical devices.

Key issues included the absence of written procedures for Medical Device Reporting (MDR). Furthermore, the firm's procedures for routinely calibrating equipment were inadequate, with specific testing instruments found uncalibrated since April 2020, despite internal requirements for pre-use validation. Documentation for corrective and preventive action (CAPA) activities was also found insufficient, as responsible individuals for several CAPA reports were not recorded. Lastly, multiple device history records (DHRs) did not demonstrate manufacturing adherence to device master records (DMRs), specifically lacking required signatures from both assemblers and supervisors. Spinergy, Inc. has committed to implementing corrective actions for these observations, with target completion dates set between September 1 and September 30, 2023, to ensure compliance with quality system requirements.