Cardinal Health 200 Inc
Form 483 issued May 22, 2015 · Denver, Colorado
- Inspection
- May 20 – May 22, 2015
- Investigator
- Ashleigh P. Wodushek
- Observations
- 1
- Pages
- 2
- FEI number
- 3008500488
In short: On May 22, 2015, FDA issued a Form 483 with 1 observation to Cardinal Health 200 Inc in Denver, Colorado (FEI 3008500488) after an inspection that ran May 20 – May 22, 2015. The investigator was Ashleigh P. Wodushek. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
This inspection in context
Ashleigh P. Wodushek
2 documents · 2015
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Colorado.
The firmCardinal Health 200 Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cardinal Health 200 Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Cardinal Health 200 Inc?
Ashleigh P. Wodushek is named on this Form 483, for the inspection of May 20 – May 22, 2015. Each investigator has a profile showing what they cite most.
When was Cardinal Health 200 Inc inspected by FDA?
The inspection ran May 20 – May 22, 2015, and the Form 483 is dated May 22, 2015.
How do I get the full Form 483 for Cardinal Health 200 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.