FDA 483 - AirScan Inc. d/b/a HemaTechnologies - March 24, 2023

An FDA inspection of AirScan Inc. d/b/a HemaTechnologies in Lebanon, NJ, identified nine significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for critical areas such as complaint handling, rework, corrective and preventive actions, and vendor management. These observations indicate a broad lack of adherence to quality system requirements for their medical devices.