FDA Inspection
Baxter Healthcare CorpBaxter Healthcare Corp – FDA Inspection, Aug 24, 2012
Record Details
This FDA Inspection record concerns Baxter Healthcare Corp, with an inspection on August 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Baxter Healthcare Corp
- Inspection Date
- August 24, 2012
- Product Type
- Devices
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ID · ab882a50-4b38-4ce9-bbdf-b2f8734a447e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794738
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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Other FDA inspections of Baxter Healthcare Corp
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 23, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 7, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Baxter Healthcare Corp
- FDA Inspection 924898 - 2015-05-05
- FDA Inspection 660253 - 2010-04-23
- FDA Inspection 588515 - 2009-04-07
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