# FDA 483 - Insulet Corporation - March 31, 2025

Source: https://www.globalkeysolutions.net/records/483/insulet-corporation/774d070a-6e94-4686-aa01-b89f7433229f

> FDA 483 for Insulet Corporation on March 31, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Insulet Corporation
- Inspection Date: 2025-03-31
- Product Type: device
- Office Name: New England District Office
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2015-03-27](https://www.globalkeysolutions.net/records/warning_letter/insulet-corporation/6afcea9c-d443-4040-8763-3e434a7daac0)

## Related Officers

- [Nabil Nakhoul](https://www.globalkeysolutions.net/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.globalkeysolutions.net/companies/insulet-corporation/afd8ec22-89bb-4732-bf46-57d767b9d53c

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144