American National Red Cross Heart of America Region
Form 483 issued August 18, 2010 · Peoria, Illinois
- Inspection
- Jun 21 – Aug 18, 2010
- Investigator
- Laurie A. Haxel
- Observations
- 5
- Pages
- 11
- FEI number
- 1473043
In short: On August 18, 2010, FDA issued a Form 483 with 5 observations to American National Red Cross Heart of America Region in Peoria, Illinois (FEI 1473043) after an inspection that ran Jun 21 – Aug 18, 2010. The investigator was Laurie A. Haxel. Most observations concern biologics CGMP.
At a glance
5 of 5 observations on this 483 concern biologics cgmp.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure of c:tistnbution and receipt procedures to include a system by which the distribution or receipt…
- 02
Written standard operating procedures including all steps to be followed in the collection and distribution of…
- 03
A thorough investigation ofeach reported adverse…
- 04
The personnel responsible for the collection of blood or blood components are not adequate in number…
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 606.165
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 5 observations on this Form 483, mostly about biologics CGMP. 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 Jun 21 – Aug 18, 2010. 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 Jun 21 – Aug 18, 2010, and the Form 483 is dated August 18, 2010.
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.