American Red Cross Greater Alleghenies Regio
Form 483 issued September 16, 2008 · Johnstown, Pennsylvania
- Inspection
- Aug 29 – Sep 16, 2008
- Investigator
- Travis R. Hunt
- Observations
- 3
- Pages
- 4
- FEI number
- 2573016
In short: On September 16, 2008, FDA issued a Form 483 with 3 observations to American Red Cross Greater Alleghenies Regio in Johnstown, Pennsylvania (FEI 2573016) after an inspection that ran Aug 29 – Sep 16, 2008. The investigator was Travis R. Hunt. Most observations concern quality system and biologics CGMP; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 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
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Failure to petform a tilorough investigation…
- 03
Written standard operating procedures including all steps to be followed in the collection, processing, storage, and…
This inspection in context
Travis R. Hunt
3 documents · 2008–2010
Cites 1271.160(b)(1) (establishment and maintenance of a quality program) 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 211.192
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 3 observations on this Form 483, mostly about quality system and biologics CGMP. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected American Red Cross Greater Alleghenies Regio?
Travis R. Hunt is named on this Form 483, for the inspection of Aug 29 – Sep 16, 2008. Each investigator has a profile showing what they cite most.
When was American Red Cross Greater Alleghenies Regio inspected by FDA?
The inspection ran Aug 29 – Sep 16, 2008, and the Form 483 is dated September 16, 2008.
How do I get the full Form 483 for American Red Cross Greater Alleghenies Regio?
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