FDA Inspection 712413 — Baxter Healthcare Corporation

Baxter Healthcare Corporation — FEI 3006472186

The FDA completed an inspection of Baxter Healthcare Corporation on Jan 5, 2011 in Mountain View, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 5, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Mountain View, CA (United States)

Additional details

Sponsor, Contract Research Organization

Citations

IDCFRDescription
299221 CFR 812.140(b)(2)Sponsor device shipment records inadequate

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