FDA 483 - Nemaura Pharma Limited - April 21, 2022

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.