FDA Inspection 1172102 — PWNHealth Chicago LLC.

PWNHealth Chicago LLC. — FEI 3000206414

The FDA completed an inspection of PWNHealth Chicago LLC. on Jun 17, 2022 in Hoffman Estates, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Jun 17, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Hoffman Estates, IL (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures