FDA Inspection 811597 — Replication Medical, Inc.

Replication Medical, Inc. — FEI 3004641714

The FDA completed an inspection of Replication Medical, Inc. on Dec 14, 2012 in Monmouth Junction, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Dec 14, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Monmouth Junction, NJ (United States)

Citations

IDCFRDescription
319221 CFR 820.30(g)Design validation - user needs and intended uses