FDA Inspection
Evenflo Co IncEvenflo Co Inc – FDA Inspection, Feb 2, 2009
Record Details
This FDA Inspection record concerns Evenflo Co Inc, with an inspection on February 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Evenflo Co Inc
- Inspection Date
- February 2, 2009
- Product Type
- Devices
View Company Profile
ID · cc83f684-7172-4b47-823c-d896d935ba44
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 565407
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
17- 21 CFR 56.103(a)IRB review requirement
- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)(1)Statistical methodology
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)(7)Management review of CAPA
- 21 CFR 820.20Management responsibility
Showing 10 of 17 citations.
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Other FDA inspections of Evenflo Co Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 4, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Evenflo Co Inc
- FDA Inspection 814561 - 2013-01-17
- FDA Inspection 651447 - 2010-03-04
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