FDA 483 - Hightech American Industrial Laboratories, Inc. - January 25, 2022

An FDA inspection of Hightech American Industrial Laboratories, Inc. in Lexington, MA, revealed a significant compliance issue related to medical device labeling. The firm failed to establish a Unique Device Identifier (UDI) for its Eyebank Specular Microscope EB-3000XYZ, resulting in shipments without UDI since 2016. This indicates a lapse in ensuring proper identification and traceability for their medical devices.