FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Aug 31, 2010
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on August 31, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 31, 2010
- Product Type
- Devices
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ID · d223fb4c-7c23-42ce-a031-3d37ab9b6eeb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680948
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Baxter Healthcare Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2025 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| September 28, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 21, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 28, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 8, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1266023 - 2025-04-04
- FDA Inspection 1153203 - 2021-09-28
- FDA Inspection 1022579 - 2017-08-21
- FDA Inspection 797090 - 2012-08-28
- FDA Inspection 700499 - 2010-12-08
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