American National Red Cross Great Lakes Region
Form 483 issued March 21, 2008 · Lansing, Michigan
- Inspection
- Mar 3 – Mar 21, 2008
- Investigator
- Kelley Clark
- Observations
- 4
- Pages
- 3
- FEI number
- 1873033
In short: On March 21, 2008, FDA issued a Form 483 with 4 observations to American National Red Cross Great Lakes Region in Lansing, Michigan (FEI 1873033) after an inspection that ran Mar 3 – Mar 21, 2008. The investigator was Kelley Clark. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
4 of 4 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (4×) · 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
Failure to identify, investigate, and correct a problem and to gain control of suspect…
- 02
Failure to perform consignee notification within 48 hours of receiving notification of suspect product and failure…
- 03
Failure to perform a…
- 04
Failure to promptly implement corrective action related…
This inspection in context
Kelley Clark
3 documents · 2008–2010
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in Michigan.
The firmAmerican National Red Cross Great Lakes Region history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Great Lakes Region?
FDA listed 4 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 Great Lakes Region?
Kelley Clark is named on this Form 483, for the inspection of Mar 3 – Mar 21, 2008. Each investigator has a profile showing what they cite most.
When was American National Red Cross Great Lakes Region inspected by FDA?
The inspection ran Mar 3 – Mar 21, 2008, and the Form 483 is dated March 21, 2008.
How do I get the full Form 483 for American National Red Cross Great Lakes Region?
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.