# FDA 483 - PWNHealth Chicago LLC. - June 17, 2022

Source: https://www.globalkeysolutions.net/records/483/pwnhealth-chicago-llc/8db8f751-8384-475d-8881-823d32ac608c

> FDA 483 for PWNHealth Chicago LLC. on June 17, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PWNHealth Chicago LLC.
- Inspection Date: 2022-06-17
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of PWNHealth Chicago LLC in Hoffman Estates, IL, a manufacturer of Class 2 medical devices, revealed two significant quality system deficiencies. The firm failed to adequately establish procedures for evaluating complaints, leading to numerous complaints not being properly investigated. Additionally, device history records were not adequately maintained, with several missing required final inspection reports.

## Related Officers

- [Natasha R. Johnson](https://www.globalkeysolutions.net/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

Company: https://www.globalkeysolutions.net/companies/pwnhealth-chicago-llc/6d4256e7-971f-448a-861f-ee9617a6aa2c

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669