FDA Inspection
Baxter Healthcare Renal DivBaxter Healthcare Renal Div – FDA Inspection, Mar 29, 2011
Record Details
This FDA Inspection record concerns Baxter Healthcare Renal Div, with an inspection on March 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Baxter Healthcare Renal Div
- Inspection Date
- March 29, 2011
- Product Type
- Devices
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ID · c95cddfb-7d9d-4083-b217-494ce17a6df8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 715840
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.52(c)(1)Brand Name
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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Other FDA inspections of Baxter Healthcare Renal Div
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 14, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Baxter Healthcare Renal Div
- FDA Inspection 774519 - 2012-03-28
- FDA Inspection 635177 - 2009-12-14
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