American National Red Cross
Amended 483 issued July 25, 2008 · Portland, New York
- Inspection
- Jul 21 – Jul 25, 2008
- Investigator
- Alexander M. Kay
- Observations
- 1
- Pages
- 2
- FEI number
- 1000307460
In short: On July 25, 2008, FDA issued a Amended 483 with 1 observation to American National Red Cross in Portland, New York (FEI 1000307460) after an inspection that ran Jul 21 – Jul 25, 2008. The investigator was Alexander M. Kay. 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 amended 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 procedures including all steps to be followed in the processing of blood and…
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Alexander M. Kay
1 document · 2008
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in New York.
The firmAmerican National Red Cross history
The site's inspection history, in date order.
Similar documentsOther sites cited under 606.100
See how FDA wrote the same problem up elsewhere.
Questions about this amended 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?
Alexander M. Kay is named on this Amended 483, for the inspection of Jul 21 – Jul 25, 2008. Each investigator has a profile showing what they cite most.
When was American National Red Cross inspected by FDA?
The inspection ran Jul 21 – Jul 25, 2008, and the Amended 483 is dated July 25, 2008.
How do I get the full Amended 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.