FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Mar 18, 2011
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on March 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 18, 2011
- Product Type
- Devices
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ID · f8019299-f1f9-4b56-a7ec-0cb16c44ee5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 707318
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Baxter Healthcare Corporation
19| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2026 | Not classified | Chicago District Office | Drug Quality Assurance |
| November 25, 2025 | Not classified | Chicago District Office | Blood and Blood Products |
| August 1, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 26, 2018 | Not classified | Chicago District Office |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1311078 - 2026-04-02
- FDA Inspection 1293034 - 2025-11-25
- FDA Inspection 1243362 - 2024-08-01
- FDA Inspection 1215194 - 2023-08-18
- FDA Inspection 1068273 - 2018-09-26
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