The National American Red Cross
Form 483 issued November 25, 2003 · Costa Mesa, California
- Inspection
- Oct 20 – Nov 25, 2003
- Investigators
- Gene D. Arcy· Selene T. Torres· Tania Y. Hall
- Observations
- 13
- Pages
- 4
In short: On November 25, 2003, FDA issued a Form 483 with 13 observations to The National American Red Cross in Costa Mesa, California after an inspection that ran Oct 20 – Nov 25, 2003. The investigators were Gene D. Arcy, Selene T. Torres and Tania Y. Hall. Most observations concern management controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Observations span 1 system, led by management controls.
Most cited: 21 CFR 820.20 (3×) · 820.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Management with executive responsibility has not ensured that an adequate and effective quality system has been…
- 02
Management with executive responsibility has not ensured that the quality policy has been fully implemented and…
- 03
Employees do not have the necessary training…
- 04
Procedures addressing identification of relevant information to be submitted for management…
This inspection in context
Gene D. Arcy
16 documents · 2003–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmThe National American Red Cross history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The National American Red Cross?
FDA listed 13 observations on this Form 483, mostly about management controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected The National American Red Cross?
Gene D. Arcy, Selene T. Torres and Tania Y. Hall are named on this Form 483, for the inspection of Oct 20 – Nov 25, 2003. Each investigator has a profile showing what they cite most.
When was The National American Red Cross inspected by FDA?
The inspection ran Oct 20 – Nov 25, 2003, and the Form 483 is dated November 25, 2003.
How do I get the full Form 483 for The National American 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.