FDA Inspection
Baxter Corporation Englewood Daytona BeachBaxter Corporation Englewood Daytona Beach – FDA Inspection, Feb 5, 2010
Record Details
This FDA Inspection record concerns Baxter Corporation Englewood Daytona Beach, with an inspection on February 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 5, 2010
- Product Type
- Devices
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ID · 7a82d0d2-eb80-4f5f-b32d-40684411db1c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 644542
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(e)(6)Results of investigation
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Other FDA inspections of Baxter Corporation Englewood Daytona Beach
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2013 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Baxter Corporation Englewood Daytona Beach
- FDA Inspection 856596 - 2013-11-06
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