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

During an inspection conducted on August 14-15, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Spinergy, Inc (SM Power LLC), a Class II medical device manufacturer in San Marcos, CA. The inspection revealed four significant observations concerning the firm's quality system and compliance with federal regulations.

Key issues included the absence of written Medical Device Reporting (MDR) procedures, a critical requirement for tracking and reporting adverse events. Additionally, procedures for ensuring routine equipment calibration were found to be inadequate, with specific testing equipment lacking current calibration status since April 2020. The FDA also noted deficiencies in the documentation of corrective and preventive action (CAPA) activities, specifically failing to identify personnel responsible for certain CAPA reports. Finally, several Device History Records (DHRs) did not fully demonstrate manufacturing in accordance with Device Master Records (DMRs), specifically lacking required assembler and supervisor signatures for device release.

These observations indicate deviations from the quality system requirements expected of medical device manufacturers. Spinergy, Inc. has committed to addressing these issues, with target completion dates ranging from September 1 to September 30, 2023, to ensure compliance with the Federal Food, Drug, and Cosmetic Act.