FDA Inspection 996501 — Uroplasty LLC

Uroplasty LLC — FEI 3002647932

The FDA completed an inspection of Uroplasty LLC on November 1, 2016 in Minnetonka, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 1, 2016
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Minnetonka, MN (United States)

Citations

IDCFRDescription
73221 CFR 803.50(a)(2)Individual Report of Malfunction