FDA Inspection 913852 — Philips Medizin Systeme Boeblingen Gmbh

Philips Medizin Systeme Boeblingen Gmbh — FEI 3002807167

The FDA completed an inspection of Philips Medizin Systeme Boeblingen Gmbh on January 29, 2015 in Boblingen. 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
January 29, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Boblingen (Germany)

Citations

IDCFRDescription
73221 CFR 803.50(a)(2)Individual Report of Malfunction