# FDA 483 - SUREPULSE MEDICAL LTD - August 01, 2024

Source: https://www.globalkeysolutions.net/records/483/surepulse-medical-ltd/8a1892bc-17a3-41e8-a890-378ed8e3b583

> FDA 483 for SUREPULSE MEDICAL LTD on August 01, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SUREPULSE MEDICAL LTD
- Inspection Date: 2024-08-01
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/surepulse-medical-ltd/9ca5d2f6-b012-4027-863f-b08562283db1

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd