FDA Inspection
Fenwal IncFenwal Inc – FDA Inspection, Mar 20, 2009
Record Details
This FDA Inspection record concerns Fenwal Inc, with an inspection on March 20, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fenwal Inc
- Inspection Date
- March 20, 2009
- Product Type
- Devices
View Company Profile
ID · 8fa0c39e-3e85-4112-832e-b9e9efcc474d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 571368
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)(5)Changes to correct/prevent quality problems
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)(3)Identification of actions needed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fenwal Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fenwal Inc
- FDA Inspection 1025637 - 2017-08-07
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