FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Sep 23, 2026
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on September 23, 2026, issued by the San Juan District Office, covering human drugs.
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ID · c638b85a-360f-4e29-97e5-0c4c0d759d95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1337134
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 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
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 15, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 17, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 8, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 12, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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