American Red Cross Greater Alleghenies Regio
Form 483 issued September 24, 2010 · Johnstown, Pennsylvania
- Inspection
- Sep 7 – Sep 24, 2010
- Investigators
- Marjorie L. Davis· Travis R. Hunt
- Observations
- 5
- Pages
- 5
- FEI number
- 2573016
In short: On September 24, 2010, FDA issued a Form 483 with 5 observations to American Red Cross Greater Alleghenies Regio in Johnstown, Pennsylvania (FEI 2573016) after an inspection that ran Sep 7 – Sep 24, 2010. The investigators were Marjorie L. Davis and Travis R. Hunt. Most observations concern biologics CGMP and production.
At a glance
3 of 5 observations on this 483 concern biologics cgmp.
What FDA observed
Preview: the opening words of each observation- 01
A thorough investigation of each reported adverse…
- 02
The personnel responsible for the collection of blood or blood components are not adequate in training…
- 03
Written standard operating procedures including all steps to be followed in the collection of blood and…
- 04
Written procedures are not reviewed and approved by…
This inspection in context
Marjorie L. Davis
1 document · 2010
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAmerican Red Cross Greater Alleghenies Regio history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 606.170(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Red Cross Greater Alleghenies Regio?
FDA listed 5 observations on this Form 483, mostly about biologics CGMP and production. The opening words of each observation are shown on this page.
Who inspected American Red Cross Greater Alleghenies Regio?
Marjorie L. Davis and Travis R. Hunt are named on this Form 483, for the inspection of Sep 7 – Sep 24, 2010. Each investigator has a profile showing what they cite most.
When was American Red Cross Greater Alleghenies Regio inspected by FDA?
The inspection ran Sep 7 – Sep 24, 2010, and the Form 483 is dated September 24, 2010.
How do I get the full Form 483 for American Red Cross Greater Alleghenies Regio?
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.