# FDA 483 - Medivance Instruments Ltd. - August 11, 2022

Source: https://www.globalkeysolutions.net/records/483/medivance-instruments-ltd/3547e6b5-a979-4e2d-9ec3-5f1a3f2cfe68

> FDA 483 for Medivance Instruments Ltd. on August 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medivance Instruments Ltd.
- Inspection Date: 2022-08-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Medivance Instruments Ltd., a medical device manufacturer in London, was cited for significant quality system deficiencies during an FDA inspection. Observations included failure to submit a timely Medical Device Report for a serious injury, inadequate complaint handling, and a lack of established procedures for CAPA, design changes, software validation, and device history records. These issues indicate a broad breakdown in the firm's quality management system.

## Related Documents

- [WARNING_LETTER - 2022-08-11](https://www.globalkeysolutions.net/records/warning_letter/medivance-instruments-ltd/ae1ec61c-61e5-4c4e-9bb4-23dbd5419bbc)

## Related Officers

- [Jude C. Dike](https://www.globalkeysolutions.net/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.globalkeysolutions.net/companies/medivance-instruments-ltd/47536dc2-9dd2-4805-84e0-e18a386963b6

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