# FDA 483 - Nemaura Pharma Limited - April 21, 2022

Source: https://www.globalkeysolutions.net/records/483/nemaura-pharma-limited/113617a9-24c4-4bda-80fb-83b8c1c14ae4

> FDA 483 for Nemaura Pharma Limited on April 21, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nemaura Pharma Limited
- Inspection Date: 2022-04-21
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Nemaura Pharma Limited in Loughborough, United Kingdom, identified one significant observation related to design controls for their sugarBEAT constant glucose monitor. The firm's design verification study for the device's sensor failed to demonstrate that critical performance criteria, such as sensitivity, detection limit, and linear regression, could be met. This indicates a deficiency in ensuring that the device design output meets its specified input requirements.

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/nemaura-pharma-limited/a4f8477c-0da0-4cab-ba7a-0a778448e9db

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