FDA Inspection
Baxter Healthcare Pty LtdBaxter Healthcare Pty Ltd – FDA Inspection, Apr 9, 2019
Record Details
This FDA Inspection record concerns Baxter Healthcare Pty Ltd, with an inspection on April 9, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 70c72fea-248d-4008-993d-963a257f141c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085648
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.110(b)In-process materials specifications testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.188(b)(10)Documentation of Sampling Performed
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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Other FDA inspections of Baxter Healthcare Pty Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 5, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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