FDA Inspection 1232002 — Radialogica LLC

Radialogica LLC — FEI 3009140718

The FDA completed an inspection of Radialogica LLC on Mar 6, 2024 in Saint Louis, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Mar 6, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Saint Louis, MO (United States)

Citations

IDCFRDescription
260421 CFR 820.30(e)Design review - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints