FDA 483 - JAS Diagnostics, Inc./Drew Scientific, Inc. - April 28, 2022

JAS Diagnostics, Inc./Drew Scientific, Inc. in Miami Lakes, FL, was cited for numerous deficiencies across its quality system during an FDA inspection. Key issues include inadequate complaint handling, ineffective corrective and preventive actions, and a lack of proper process and design validations for its medical devices and reagents. The inspection revealed systemic failures in quality control, supplier management, and employee training, many of which are repeat observations from previous inspections and an Untitled Letter.