FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Nov 29, 2016
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on November 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ade99ea0-9093-49fb-86b3-e6523a2cc9f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000057
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
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Other FDA inspections of Baxter Healthcare Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 10, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 5, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 839920 - 2013-07-12
- FDA Inspection 724794 - 2011-05-10
- FDA Inspection 712413 - 2011-01-05
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