FDA 483 - Millstone Medical Outsourcing, LLC - December 18, 2024

Millstone Medical Outsourcing, LLC in Fall River, MA, a medical device manufacturer, was cited for inadequate process validation during an FDA inspection. Specifically, their heat process for device cartons was not qualified, leading to undefined parameters and a lack of documentation for the number of passes through the oven tunnel. This deficiency resulted in multiple complaints of melted or warped medical device trays.