FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Nov 17, 2017
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on November 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c70d8cf6-ee98-4a1e-9d34-422e372ef98d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031655
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Baxter Healthcare Corporation
10| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 31, 2023 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 12, 2022 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 1, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 26, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1230544 - 2024-02-09
- FDA Inspection 1221559 - 2023-10-31
- FDA Inspection 1169330 - 2022-05-12
- FDA Inspection 1151566 - 2021-07-01
- FDA Inspection 969544 - 2016-02-26
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