FDA 483 - JAS Diagnostics, Inc./Drew Scientific, Inc. - June 12, 2025

JAS Diagnostics, Inc./Drew Scientific, Inc. in Miami Lakes, FL, was inspected and cited for significant quality system deficiencies. Observations included inadequate process validation, failure to maintain complaint files and conduct investigations, and lack of established design control procedures. Additionally, the firm failed to adequately implement supplier controls and did not document personnel training or evaluate its effectiveness, with some employees lacking required training for over a decade.