# FDA 483 - Beta Bionics, Inc - June 26, 2025

Source: https://www.globalkeysolutions.net/records/483/beta-bionics-inc/8e8c3dfd-995e-4c6b-a384-b8c52791b079

> FDA 483 for Beta Bionics, Inc on June 26, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beta Bionics, Inc
- Inspection Date: 2025-06-26
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Beta Bionics, Inc. received a Form FDA-483 for deficiencies in its quality system related to the iLet Bionic Pancreas System. The inspection revealed significant issues with timely Medical Device Reporting, inadequate complaint handling procedures, and insufficient corrective and preventive actions. These deficiencies led to failures in reporting serious adverse events like diabetic ketoacidosis and severe hypoglycemia, and a lack of proper investigation and risk mitigation for device malfunctions and user errors.

## Related Documents

- [483 - 2025-06-26](https://www.globalkeysolutions.net/records/483/beta-bionics-inc/9af47214-da73-462b-b636-d172b6317b0a)
- [WARNING_LETTER - 2025-06-26](https://www.globalkeysolutions.net/records/warning_letter/beta-bionics-inc/c618dde7-c17f-4ba7-9227-9c89777cd93c)
- [WARNING_LETTER - 2025-06-26](https://www.globalkeysolutions.net/records/warning_letter/beta-bionics-inc/c6b1f368-96fc-4e24-ac7a-648fd522cbdb)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)
- [Investigator](https://www.globalkeysolutions.net/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.globalkeysolutions.net/companies/beta-bionics-inc/275e80ad-2048-45cf-bfb7-8fd3d648b069

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6