FDA Inspection 937961 — Baxter Healthcare Corporation

Baxter Healthcare Corporation — FEI 2649614

The FDA completed an inspection of Baxter Healthcare Corporation on June 8, 2015 in Aibonito, PR. 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
June 8, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Aibonito, PR (United States)

Citations

IDCFRDescription
326321 CFR 820.250(b)Sampling plans