FDA Inspection
Cardinal Health PR 218 IncCardinal Health PR 218 Inc – FDA Inspection, Jan 29, 2013
Record Details
This FDA Inspection record concerns Cardinal Health PR 218 Inc, with an inspection on January 29, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cardinal Health PR 218 Inc
- Inspection Date
- January 29, 2013
- Product Type
- Devices
View Company Profile
ID · e385c05a-2472-47ac-97c2-e57544d46c33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817049
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
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Other FDA inspections of Cardinal Health PR 218 Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 15, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Cardinal Health PR 218 Inc
- FDA Inspection 993501 - 2016-11-16
- FDA Inspection 710940 - 2011-02-15
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