FDA Inspection 634828 — Baxter Healthcare Corporation

Baxter Healthcare Corporation — FEI 1036337

The FDA completed an inspection of Baxter Healthcare Corporation on December 16, 2009 in Largo, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 16, 2009
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Largo, FL (United States)

Citations

IDCFRDescription
329921 CFR 820.100(a)(1)Procedure for analysis of data sources
418921 CFR 820.198(a)General