FDA Inspection 1072203 — Baxter Healthcare Corporation

Baxter Healthcare Corporation — FEI 1019003

The FDA completed an inspection of Baxter Healthcare Corporation on November 20, 2018 in Cleveland, MS. 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 20, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cleveland, MS (United States)

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented