American National Red Cross
Form 483 issued August 13, 2010 · Roanoke, Virginia
- Inspection
- Aug 3 – Aug 13, 2010
- Investigator
- L. N. C. Wr
- Observations
- 1
- Pages
- 3
- FEI number
- 1173010
In short: On August 13, 2010, FDA issued a Form 483 with 1 observation to American National Red Cross in Roanoke, Virginia (FEI 1173010) after an inspection that ran Aug 3 – Aug 13, 2010. The investigator was L. N. C. Wr. 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 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written standard operating p!u~.;roures tnctuamg all steps to be followed in tlie.ooliectio~,-of.qlooci .a~~ blood components for…
This inspection in context
L. N. C. Wr
1 document · 2010
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in Virginia.
The firmAmerican National Red Cross history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.100
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?
L. N. C. Wr is named on this Form 483, for the inspection of Aug 3 – Aug 13, 2010. Each investigator has a profile showing what they cite most.
When was American National Red Cross inspected by FDA?
The inspection ran Aug 3 – Aug 13, 2010, and the Form 483 is dated August 13, 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.