FDA Inspection 1171229 — Physician Software Systems LLC

Physician Software Systems LLC — FEI 3010728384

The FDA completed an inspection of Physician Software Systems LLC on Jun 6, 2022 in Lisle, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.

Inspection details

Classification
No Action Indicated (NAI)
End Date
Jun 6, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Lisle, IL (United States)

Citations

IDCFRDescription
316021 CFR 820.184Lack of or inadequate DHR procedures
317021 CFR 820.198(b)Review and evaluation for investigation
333121 CFR 820.181DMR - not or inadequately maintained
369621 CFR 820.100(b)Documentation

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.