FDA 483 - International Medical Development, Inc. - February 12, 2021

An FDA inspection of International Medical Development, Inc. in Huntsville, UT, a specification developer, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for design change, supplier control, non-conforming product, corrective and preventive actions, labeling, device master records, device history records, internal audits, and management review. Several observations were repeats from prior FDA inspections and a Warning Letter, indicating persistent quality system issues.