FDA Inspection
Baxter Healthcare S.A.Baxter Healthcare S.A. – FDA Inspection, Oct 14, 2014
Record Details
This FDA Inspection record concerns Baxter Healthcare S.A., with an inspection on October 14, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Baxter Healthcare S.A.
- Inspection Date
- October 14, 2014
- Product Type
- Drugs
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ID · d6b891cf-d9ab-4454-9abf-598f79e3f9c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 907572
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Baxter Healthcare S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 6, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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