FDA 483 - Med Labs Inc - August 20, 2024

An FDA inspection of Med Labs Inc in Goleta, CA, conducted from August 19-20, 2024, identified one significant observation. The firm failed to ensure that the labels of their Class II medical devices, specifically muscle simulators and a portable alarm, bore unique device identifiers (UDI) as required by regulations. This indicates a non-compliance with UDI labeling requirements for their medical devices.