FDA 483 - Insulet Corporation - March 31, 2025
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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.
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ID · 774d070a-6e94-4686-aa01-b89f7433229f