FDA Inspection 578055 — Maquet Cardiovascular, LLC

Maquet Cardiovascular, LLC — FEI 2242352

The FDA completed an inspection of Maquet Cardiovascular, LLC on April 17, 2009 in Wayne, NJ. 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
April 17, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Wayne, NJ (United States)

Citations

IDCFRDescription
320621 CFR 820.50(b)Approval, inadequate purchasing data