FDA Inspection 936229 — Penumbra Inc.

Penumbra Inc. — FEI 3005168196

The FDA completed an inspection of Penumbra Inc. on August 4, 2015 in Alameda, CA. 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
August 4, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Alameda, CA (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures