FDA 483 - Vacumed, Div of Vacumetrics Inc - September 13, 2023

Vacumed, Div of Vacumetrics Inc. in San Buenaventura, CA, a medical device manufacturer, received a Form FDA 483 with three observations. The inspection revealed deficiencies in process validation, inadequate maintenance of device history records for Class II medical devices, and an insufficient corrective and preventive action system. These issues indicate a lack of robust quality system procedures and record-keeping at the facility.