FDA 483 - JAS Diagnostics, Inc./Drew Scientific, Inc. - August 29, 2019

JAS Diagnostics/Drew Scientific, Inc./Diamedix Corp. in Miami Lakes, FL, was inspected and cited for significant deficiencies across its quality system for medical devices. The inspection revealed inadequate organizational structure, incomplete corrective and preventive actions, missing design history files, and insufficient risk analysis and process validation. Several observations were repeats from previous inspections, indicating a persistent lack of compliance.