FDA Inspection 945195 — Medtronic Xomed, Inc.

Medtronic Xomed, Inc. — FEI 1000159144

The FDA completed an inspection of Medtronic Xomed, Inc. on Sep 21, 2015 in Mystic, CT. 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
Sep 21, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Mystic, CT (United States)

Citations

IDCFRDescription
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ