American National Red Cross Heart of America Region
Form 483 issued October 17, 2008 · Peoria, Illinois
- Inspection
- Sep 10 – Oct 17, 2008
- Investigator
- Laurie A. Haxel
- Observations
- 3
- Pages
- 4
- FEI number
- 1473043
In short: On October 17, 2008, FDA issued a Form 483 with 3 observations to American National Red Cross Heart of America Region in Peoria, Illinois (FEI 1473043) after an inspection that ran Sep 10 – Oct 17, 2008. The investigator was Laurie A. Haxel. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
3 of 3 observations on this 483 concern biologics cgmp.
What FDA observed
Preview: the opening words of each observation- 01
Failure tQ perform a thorough…
- 02
Written standard operating procedures including all steps to be followed in the collection and processing of…
- 03
A thorough investigation of each report of adverse…
This inspection in context
Laurie A. Haxel
3 documents · 2008–2010
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in Illinois.
The firmAmerican National Red Cross Heart of America Region history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 606.100(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American National Red Cross Heart of America Region?
FDA listed 3 observations 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 Heart of America Region?
Laurie A. Haxel is named on this Form 483, for the inspection of Sep 10 – Oct 17, 2008. Each investigator has a profile showing what they cite most.
When was American National Red Cross Heart of America Region inspected by FDA?
The inspection ran Sep 10 – Oct 17, 2008, and the Form 483 is dated October 17, 2008.
How do I get the full Form 483 for American National Red Cross Heart of America Region?
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.