# FDA 483 - Pleural Dynamics, Inc. - January 13, 2026

Source: https://www.keypedia.com/records/483/pleural-dynamics-inc/0d586aa8-c59f-4e0a-a74e-6c22ad95de3f

> FDA 483 for Pleural Dynamics, Inc. on January 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pleural Dynamics, Inc.
- Inspection Date: 2026-01-13
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Pleural Dynamics, Inc., a medical device manufacturer in Minnetonka, MN, revealed significant deficiencies in their quality management system. The firm failed to adequately establish procedures for corrective and preventive actions, conduct documented management reviews, perform internal quality audits, and monitor suppliers. These observations indicate a systemic lack of adherence to established quality system requirements.

## Related Officers

- [Benjamin W. Anderson](https://www.keypedia.com/people/benjamin-w-anderson/a3c0961c-6a83-4bd7-abb8-02c5c8dd3a35)

Company: https://www.keypedia.com/companies/pleural-dynamics-inc/6bba31c7-1bb9-4ca6-9334-1aa57cc206dc

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d