FDA Inspection
Baxter Healthcare S.A.Baxter Healthcare S.A. – FDA Inspection, Feb 6, 2018
Record Details
This FDA Inspection record concerns Baxter Healthcare S.A., with an inspection on February 6, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f7ddef51-d79a-433a-bb25-0e0a5f551e6e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039972
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.198(a)Complaint Handling Procedure
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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 |
| October 14, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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