FDA 483 - Vega Technologies Inc. - November 10, 2023

An FDA inspection conducted at Vega Technologies Inc., a medical device manufacturer, from November 7-10, 2023, identified six significant observations outlined in a Form FDA 483. The inspection highlighted critical deficiencies in the company's quality management system, indicating non-compliance with regulatory requirements. Key violations included inadequate procedures for design validation, specifically noting a lack of validation for Class II VEGA Medical Suction Equipment shipped to the U.S. since 2011. The firm also failed to adequately establish procedures for receiving and evaluating complaints, with serious incidents like units smoking, sparking, or catching fire, and patient burns, not consistently documented in their system. Further issues involved deficiencies in device history records (DHRs), which did not demonstrate manufacturing in accordance with device master records due to undocumented assembly processes. Process control procedures were also found insufficient, lacking proper identification and documentation for manufactured units, hindering traceability. Additionally, DHRs did not include or refer to primary identification labels or Unique Device Identifiers (UDIs). Lastly, the company's Medical Device Reporting (MDR) procedures were inadequate, lacking systems for timely event identification, evaluation, standardized review, and complete report transmission. These observations indicate significant deviations from FDA's Quality System Regulation, which mandates robust controls for medical device manufacturing. Vega Technologies Inc. has committed to correcting each identified observation.