FDA 483 - Insulet Corporation - March 31, 2025

Insulet Corporation, a medical device manufacturer in Acton, MA, received two observations during an FDA inspection. The firm was cited for inadequate documentation of corrective and preventive actions related to an Omnipod 5 Controller overheating issue and for failing to perform a risk analysis for an Omnipod 5 App issue caused by cybersecurity maintenance. These findings highlight deficiencies in the company's quality system regarding device safety and risk management.