FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Aug 21, 2017
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on August 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cf0188bd-7c8a-4ac4-870e-df35bcfc18b1
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1022579
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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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 28, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 8, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 31, 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 797090 - 2012-08-28
- FDA Inspection 700499 - 2010-12-08
- FDA Inspection 680948 - 2010-08-31
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