Ekso Bionics Inc. – FDA 483, Dec 13, 2023

From December 13 to December 21, 2023, the FDA conducted an inspection of Ekso Bionics Inc., a medical device manufacturer. The inspection resulted in an FDA Form 483 observation identifying deficiencies in the company's quality system. Specifically, procedures for controlling nonconforming product were deemed inadequate. The primary issue cited was that the "Control of Nonconforming Product" procedure (SOP-090) did not clearly define the assignment and intended use of nonconforming (NC) codes for trend analysis. Despite the procedure stating that NC codes should be used for data analysis, Ekso Bionics Inc. was not utilizing them for this purpose. Additionally, the procedure lacked a clear mechanism for integrating nonconformance data into the process risk analysis (PFMEA), and no established system was in place to update the PFMEA based on nonconformance records. The "Risk Management" procedure (SOP-034) was also noted for its lack of clarity regarding the specific data used to update the PFMEA. Under the regulatory framework governing medical device manufacturers, Ekso Bionics Inc. is responsible for implementing prompt corrective actions to ensure its quality management system effectively controls nonconforming products and accurately integrates relevant data into its risk management processes.