Stat Medical Devices, Inc. – FDA 483, Mar 18, 2025

Stat Medical Devices, Inc. in North Miami Beach, FL, a specification developer for Class II in vitro diagnostic medical devices, received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in design control, management of non-conforming products including expired sterile devices, inadequate personnel training documentation, and a failure to include Unique Device Identifiers on device labels. These issues indicate a broad lack of adherence to quality system requirements.