# FDA 483 - Ion Medical, Inc. - June 13, 2025

Source: https://www.keypedia.com/records/483/ion-medical-inc/21973f18-c07c-436d-8d0b-6085df1759c5

> FDA 483 for Ion Medical, Inc. on June 13, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ion Medical, Inc.
- Inspection Date: 2025-06-13
- Product Type: devices
- Office Name: Florida District Office
- Summary: An FDA inspection of Ion Medical, Inc., a medical device manufacturer, was conducted from June 10-13, 2025, revealing several critical quality system deficiencies. The company was cited for four primary observations, with two being repeat findings from a previous inspection. Key issues included the absence or improper execution of design change procedures, specifically regarding a Bipolar Coagulation Pen's extended lifespan. The firm failed to adhere to its own protocols, utilized inadequate testing methods lacking established industry standards, and did not ensure independent participation in design reviews.

Furthermore, Ion Medical, Inc. demonstrated significant shortcomings in its supplier control processes, such as lacking an official supplier list, not categorizing suppliers according to its own procedures, failing to complete required supplier questionnaires, and not establishing formal agreements for change notifications from suppliers.

Deficiencies were also noted in the company's quality audit procedures and their implementation. Comprehensive internal audits were not conducted regularly as required, unqualified personnel acted as lead auditors, and individuals with direct responsibility for audited areas performed the audits, compromising objectivity. Lastly, essential official documents, including the Quality Manual, lacked required approval dates and signatures from approving officials.

Ion Medical, Inc. is now responsible for addressing these observations by implementing comprehensive corrective actions to ensure full compliance with established quality system regulations.

## Related Officers

- [David M. Wilkinson](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.keypedia.com/companies/ion-medical-inc/146f9e18-db54-420b-b80e-43ab9d53848e

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9