American National Red Cross
Form 483 issued September 15, 2010 · Tucson, Arizona
- Inspection
- Sep 1 – Sep 15, 2010
- Investigator
- Tonia L. Sawyer
- Observations
- 2
- Pages
- 3
- FEI number
- 3002345935
In short: On September 15, 2010, FDA issued a Form 483 with 2 observations to American National Red Cross in Tucson, Arizona (FEI 3002345935) after an inspection that ran Sep 1 – Sep 15, 2010. The investigator was Tonia L. Sawyer. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.170 (adverse reaction file).
At a glance
2 of 2 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.170 (1×) · 606.170(a) (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
A thoi'OUgh Investigation of each reported adverse…
This inspection in context
Tonia L. Sawyer
1 document · 2010
Cites 606.170 (adverse reaction file) more than any other section. Most of their documents are for sites in Arizona.
The firmAmerican National Red Cross history
All 16 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 606.170
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American National Red Cross?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.170 (adverse reaction file). The opening words of each observation are shown on this page.
Who inspected American National Red Cross?
Tonia L. Sawyer is named on this Form 483, for the inspection of Sep 1 – Sep 15, 2010. Each investigator has a profile showing what they cite most.
When was American National Red Cross inspected by FDA?
The inspection ran Sep 1 – Sep 15, 2010, and the Form 483 is dated September 15, 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.