# FDA 483 - Polarean, Inc. - September 07, 2021

Source: https://www.globalkeysolutions.net/records/483/polarean-inc/835f737f-fef4-4bfa-bd44-046f32a5d692

> FDA 483 for Polarean, Inc. on September 07, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Polarean, Inc.
- Inspection Date: 2021-09-07
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Polarean Inc. in Durham, NC, a combo drug/device manufacturer, was inspected by the FDA from August 30 to September 7, 2021. The inspection revealed a significant issue with design validation, specifically that the hyperpolarizer device was not validated using production-equivalent units. Furthermore, changes made to the device and a change in contract manufacturer were not properly documented or re-evaluated, indicating potential deficiencies in quality system controls for device design and manufacturing.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/david-e-lowe/1a2492c2-4a81-4486-b3af-37f6b7b5216a)
- [Seneca D. Toms](https://www.globalkeysolutions.net/people/seneca-d-toms/3eda62a2-4c12-438f-805a-5e3efb0f2f94)

Company: https://www.globalkeysolutions.net/companies/polarean-inc/01946337-52b7-40ed-b8bc-92d315dcb83b

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7