# FDA 483 - Pulmodyne Inc. - April 22, 2025

Source: https://www.keypedia.com/records/483/pulmodyne-inc/e5665199-573b-40d1-8761-6d265fefbeb5

> FDA 483 for Pulmodyne Inc. on April 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pulmodyne Inc.
- Inspection Date: 2025-04-22
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Pulmodyne Inc. in Indianapolis, IN, identified significant deficiencies in the firm's design control procedures. The company failed to adequately define design outputs, verify design outputs against input requirements, and validate the device's conformity to user needs under actual or simulated use conditions. These findings indicate a lack of robust design control, which is critical for ensuring device safety and effectiveness.

## Related Officers

- [Melina L. Rodriguez-Upton](https://www.keypedia.com/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)

Company: https://www.keypedia.com/companies/pulmodyne-inc/8c17b704-2050-4c41-977d-f2141366a299

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03