FDA Inspection 777361 — Philips North America

Philips North America — FEI 3006648320

The FDA completed an inspection of Philips North America on April 13, 2012 in Cambridge, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 13, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Cambridge, MA (United States)

Citations

IDCFRDescription
41921 CFR 820.20(b)Lack of or inadequate organizational structure