PWNHealth Chicago LLC.June 17, 2022

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

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Record Details

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.

Company: PWNHealth Chicago LLC.
Inspection Date: June 17, 2022
Product Type: Device
Office: Chicago District Office
Person: Natasha R. Johnson

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ID · 8db8f751-8384-475d-8881-823d32ac608c