FDA Inspection 1046082 — Frontier Medical Products Inc.

Frontier Medical Products Inc. — FEI 1419759

The FDA completed an inspection of Frontier Medical Products Inc. on March 22, 2018 in Grafton, WI. 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
March 22, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Grafton, WI (United States)

Citations

IDCFRDescription
63021 CFR 803.17Lack of Written MDR Procedures