FDA 483 - Advanced Instrumentations, Inc. - April 17, 2025

Advanced Instruments, Inc. in Miami, FL, a specification developer, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in design control, supplier qualification, document control, complaint handling, and overall quality policy implementation, with several issues being repeat observations. The firm failed to adequately manage its contract manufacturers' design and quality processes for its medical devices.