American National Red Cross
Form 483 issued June 23, 2008 · Baltimore, Maryland
- Inspection
- May 5 – Jun 23, 2008
- Investigator
- Linda S. Mattingly
- Observations
- 6
- Pages
- 5
- FEI number
- 1173011
In short: On June 23, 2008, FDA issued a Form 483 with 6 observations to American National Red Cross in Baltimore, Maryland (FEI 1173011) after an inspection that ran May 5 – Jun 23, 2008. The investigator was Linda S. Mattingly. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
6 of 6 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (6×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Greater Chesapeake and Potomac Region (hereafter, region) failed to identify, investigate, correct and trend all…
- 02
The collection of overweight units of whole blood was addressed during the April-June 2002 and September-January…
- 03
This region is not performing required and thorough reviews of the manufacturing records before distributing blood…
- 04
The region has not implemented an effective corrective action to prevent whole blood number mix ups…
This inspection in context
Linda S. Mattingly
2 documents · 2008–2010
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in Maryland.
The firmAmerican 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 American National Red Cross?
FDA listed 6 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 American National Red Cross?
Linda S. Mattingly is named on this Form 483, for the inspection of May 5 – Jun 23, 2008. Each investigator has a profile showing what they cite most.
When was American National Red Cross inspected by FDA?
The inspection ran May 5 – Jun 23, 2008, and the Form 483 is dated June 23, 2008.
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.