FDA Inspection
Cardinal Health LLCCardinal Health LLC – FDA Inspection, Nov 15, 2017
Record Details
This FDA Inspection record concerns Cardinal Health LLC, with an inspection on November 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1e8ea29d-14a7-4f71-89d1-09271de05266
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032095
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.50(a)(2)Individual Report of Malfunction
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cardinal Health LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 17, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 15, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 19, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cardinal Health LLC
- FDA Inspection 966233 - 2016-03-23
- FDA Inspection 923902 - 2015-04-17
- FDA Inspection 762075 - 2011-12-15
- FDA Inspection 550837 - 2008-11-19
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