FDA Inspection
Baxter Healthcare Renal DivBaxter Healthcare Renal Div – FDA Inspection, Dec 14, 2009
Record Details
This FDA Inspection record concerns Baxter Healthcare Renal Div, with an inspection on December 14, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Baxter Healthcare Renal Div
- Inspection Date
- December 14, 2009
- Product Type
- Devices
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ID · f923ff38-55bd-40ac-8674-64f436075cd1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 635177
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.198(e)(7)Corrective action taken
- 21 CFR 820.30(f)Design verification - unresolved discrepancies
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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 |
| March 29, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Baxter Healthcare Renal Div
- FDA Inspection 774519 - 2012-03-28
- FDA Inspection 715840 - 2011-03-29
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