FDA 483 - SUREPULSE MEDICAL LTD - August 01, 2024

SUREPULSE MEDICAL LTD in Nottingham, United Kingdom, was inspected regarding its VS Newborn Heart Rate Monitor system. The inspection revealed significant deficiencies across its quality system, including failures to report field corrections to the FDA and inadequate corrective and preventive actions. Further issues were noted with acceptance activities, process validation, supplier control, risk analysis, and complaint handling, including evaluation for Medical Device Reporting.