FDA 483 - Vacumed, Div of Vacumetrics Inc - February 21, 2020

An FDA inspection of Vacumed, Div of Vacumetrics Inc, a Class II medical device manufacturer in Ventura, CA, revealed two significant observations. The firm was cited for failing to adequately maintain records of changes to documents, specifically Device Master Records. Additionally, procedures for corrective and preventive actions were found to be incomplete and not consistently followed.