American National Red Cross
Form 483 issued April 23, 2010 · Madison, Wisconsin
- Inspection
- Apr 5 – Apr 23, 2010
- Investigators
- Karen M. Labounty· Susan M. Miller
- Observations
- 1
- Pages
- 1
- FEI number
- 2173028
In short: On April 23, 2010, FDA issued a Form 483 with 1 observation to American National Red Cross in Madison, Wisconsin (FEI 2173028) after an inspection that ran Apr 5 – Apr 23, 2010. The investigators were Karen M. Labounty and Susan M. Miller. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written standard operating procedures including all steps to be followed in the collection of blood and…
This inspection in context
Karen M. Labounty
5 documents · 2004–2020
Cites 118.4 (salmonella enteritidis (se) prevention measures) more than any other section. Most of their documents are for sites in Minnesota.
The firmAmerican National Red Cross history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American National Red Cross?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected American National Red Cross?
Karen M. Labounty and Susan M. Miller are named on this Form 483, for the inspection of Apr 5 – Apr 23, 2010. Each investigator has a profile showing what they cite most.
When was American National Red Cross inspected by FDA?
The inspection ran Apr 5 – Apr 23, 2010, and the Form 483 is dated April 23, 2010.
How do I get the full Form 483 for American National Red Cross?
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.