Cardinal Health, Inc
Form 483 issued March 26, 2015 · El Paso, Texas
- Inspection
- Mar 23 – Mar 26, 2015
- Investigator
- Jocelyn C. Turner
- Observations
- 4
- Pages
- 4
- FEI number
- 1623223
In short: On March 26, 2015, FDA issued a Form 483 with 4 observations to Cardinal Health, Inc in El Paso, Texas (FEI 1623223) after an inspection that ran Mar 23 – Mar 26, 2015. The investigator was Jocelyn C. Turner. Most observations concern management controls and design controls.
At a glance
Management controls and design controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
- 02
A device master record has…
- 03
Procedures for quality audits have…
- 04
Procedures for management review have…
This inspection in context
Jocelyn C. Turner
10 documents · 2015–2026
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmCardinal Health, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cardinal Health, Inc?
FDA listed 4 observations on this Form 483, mostly about management controls, design controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Cardinal Health, Inc?
Jocelyn C. Turner is named on this Form 483, for the inspection of Mar 23 – Mar 26, 2015. Each investigator has a profile showing what they cite most.
When was Cardinal Health, Inc inspected by FDA?
The inspection ran Mar 23 – Mar 26, 2015, and the Form 483 is dated March 26, 2015.
How do I get the full Form 483 for Cardinal Health, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.