FDA Inspection
Cardinal HealthCardinal Health – FDA Inspection, Jan 25, 2017
Record Details
This FDA Inspection record concerns Cardinal Health, with an inspection on January 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 458bbd27-3a16-451b-80b0-3b871f19c50a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1001711
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.