The American National Red Cross
Form 483 issued May 23, 2008 · Salt Lake City, Utah
- Inspection
- Apr 14 – May 23, 2008
- Investigator
- Kelly D. Moore
- Observations
- 10
- Pages
- 5
- FEI number
- 3001451955
In short: On May 23, 2008, FDA issued a Form 483 with 10 observations to The American National Red Cross in Salt Lake City, Utah (FEI 3001451955) after an inspection that ran Apr 14 – May 23, 2008. The investigator was Kelly D. Moore. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
8 of 9 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (7×) · 606.171 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Monthly Summ Problem Reports from March of 2006 to the present documented an ongoing trend…
- 02
In December of 2006 the firm recognized a trend in BPD code _ (Collection Site Set-Up…
- 03
Since February of 2006 American Red Cross Blood Services has documented an ongoing trend in problems…
- 04
Corrective Action Plans developed to prevent the recurrence of problems submitted to the Quality Assurance…
This inspection in context
Kelly D. Moore
2 documents · 2008–2018
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in Utah.
The firmThe American 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 The American National Red Cross?
FDA listed 10 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 The American National Red Cross?
Kelly D. Moore is named on this Form 483, for the inspection of Apr 14 – May 23, 2008. Each investigator has a profile showing what they cite most.
When was The American National Red Cross inspected by FDA?
The inspection ran Apr 14 – May 23, 2008, and the Form 483 is dated May 23, 2008.
How do I get the full Form 483 for The 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.